[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Singapore\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":704},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,574,0,25,[9,54,76,98,121,140,165,196,217,237,259,289,335,365,399,466,496,515,543,567,593,618,638,659,680],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100053387",false,"NCT06318169","A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)\u002Fmeters squared (m\\^2) (≥23 kg\u002Fm\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},1350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.",[27],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[29,30,31,32,33,34,35,36,37,38,39,40],"Liver Diseases","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Steatohepatitis","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis","RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":45},"2024-03-13",{"date":49,"type":21},"2029-02",{"name":51,"class":52},"89bio, Inc.","INDUSTRY",361,{"id":55,"slug":4,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100054056","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","12 Years",{"count":62,"type":21},132,[64],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[67],"Proteinuric Kidney Diseases",{"date":44,"type":45},{"date":70,"type":45},"2026-03-23",{"date":72,"type":21},"2028-02-17",{"name":74,"class":52},"Boehringer Ingelheim",161,{"id":77,"slug":4,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":84,"type":21},1440,[24],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[88,89],"Prostate Cancer","Prostatic Neoplasms",{"date":44,"type":45},{"date":92,"type":45},"2025-05-13",{"date":94,"type":21},"2031-01-06",{"name":96,"class":52},"Merck Sharp & Dohme LLC",290,{"id":99,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100054215","NCT05744921","A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works","An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria","ACCESS-EXT","Key Inclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Patients with PNH who have completed, without permanent discontinuation, study treatment in the parent study (R3918-PNH-2021\\[NCT05133531\\]), including the post-Open-label treatment period (OLTP) transition period, if applicable.\n2. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol.\n\nPatients Entering with C5 polymorphism\n\n1. Patients with PNH who have a documented C5 polymorphism rendering them refractory to eculizumab or ravulizumab (eg, p.Arg885His, p.Arg885Cys), as described in the protocol\n2. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes\n3. Active disease, as defined by the presence of 1 or more PNH-related sign or symptom as described in the protocol\n4. LDH level ≥2 × upper limit of normal (ULN) at the screening visit\n5. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and\u002For safety of the patient\n2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study\n\nPatients Entering with C5 polymorphism\n\n1. Prior treatment with complement inhibitors within 5 half-lives of the respective agent prior to screening, except for prior eculizumab or ravulizumab which are not exclusionary\n2. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant\n3. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to enrollment and serotype B vaccine within 3 years prior to enrollment as described in the protocol\n4. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic acid (RNA) during screening\n5. Patients with known HIV with history of opportunistic infections in the last 1 year as described in the protocol\n6. Known hereditary complement deficiency\n7. Documented history of active, uncontrolled, ongoing systemic autoimmune diseases\n8. Documented history of liver cirrhosis or patients with liver disease with evidence of current impaired liver function or patients with elevations in Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (unrelated to PNH or its complications) as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":106,"type":21},202,[24],"This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as \"study drugs\" in this section.\n\nThis study is looking at several other research questions, including:\n\n* How effective is the pozelimab + cemdisiran combination?\n* What side effects may happen from taking the study drugs?\n* How much of each study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)",[110],"Paroxysmal Nocturnal Hemoglobinuria",[112],"PNH",{"date":44,"type":45},{"date":115,"type":45},"2023-03-07",{"date":117,"type":21},"2029-02-26",{"name":119,"class":52},"Regeneron Pharmaceuticals",45,{"id":122,"slug":4,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100053831","NCT06979596","A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015\u002FOMAHA-015)","A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Has a diagnosis of hormone receptor positive\u002FHuman Epidermal Growth Factor Receptor 2 negative (HR+\u002FHER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent.\n  * Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting\n* Cohort B:\n\n  * Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \\[carcinosarcoma\\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma.\n  * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer.\n* Cohort C:\n\n  * Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \\[FIGO\\] Grade 1\u002F2, or well\u002Fmoderately differentiated).\n  * Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced\u002Fmetastatic OR adjuvant\u002Fneoadjuvant setting.\n* All Cohorts :\n\n  * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.\n  * Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.\n  * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Cohort A:\n\n  * Breast cancer amenable to treatment with curative intent.\n  * Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion\u002Finfiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.\n* Cohort B:\n\n  * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.\n  * Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \\[1L\\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.\n* Cohort C:\n\n  * Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.\n  * Is a candidate for curative-intent surgery or curative-intent radiotherapy.\n* All Cohorts:\n\n  * Has confirmed or suspected adrenal metastases.\n  * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.\n  * Has any prior history or current condition of adrenal insufficiency.\n  * HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n  * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n  * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n  * Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n  * Has a history of stem cell\u002Fsolid organ transplant.\n  * Has not adequately recovered from major surgery or has ongoing surgical complications.",{"count":128,"type":21},250,[64],"Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.\n\nResearchers will compare MK-5684 to the standard treatments for each cancer type in this study.\n\nThe goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.",[132],"Malignant Neoplasm",{"date":44,"type":45},{"date":135,"type":45},"2025-08-11",{"date":137,"type":21},"2027-11-04",{"name":96,"class":52},57,{"id":141,"slug":4,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100053409","NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.","75 Years",{"count":148,"type":21},762,[24],"The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[152],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[154,30,31,32,33,34,155,156,36,37,38,39,40,157],"Liver disease","Nonalcoholic steatohepatitis","NASH","Cirrhosis",{"date":44,"type":45},{"date":160,"type":45},"2024-05-24",{"date":162,"type":21},"2031-08",{"name":51,"class":52},317,{"id":166,"slug":4,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":173,"type":21},450,[24],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[177,178],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[180,181,182,183,184,185,186,187],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":44,"type":45},{"date":190,"type":45},"2025-07-17",{"date":192,"type":21},"2029-12",{"name":194,"class":52},"Nuvalent Inc.",156,{"id":197,"slug":4,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":203,"type":21},1046,[24],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[207],"Diffuse Large B-Cell Lymphoma",[209],"Lymphoma, Large B-Cell, Diffuse",{"date":44,"type":45},{"date":212,"type":45},"2025-01-27",{"date":214,"type":21},"2032-03-29",{"name":96,"class":52},266,{"id":218,"slug":4,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":223,"maxAge":18,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years",{"count":225,"type":21},1200,[24],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[229],"Crohn's Disease",{"date":44,"type":45},{"date":232,"type":45},"2024-06-05",{"date":234,"type":21},"2029-11-12",{"name":96,"class":52},499,{"id":238,"slug":4,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":246,"type":21},342,[64,24],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[250,251],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":44,"type":45},{"date":254,"type":45},"2023-05-31",{"date":256,"type":21},"2032-04-15",{"name":96,"class":52},107,{"id":260,"slug":4,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100053363","NCT07699328","A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","REACH-EGFR","Inclusion Criteria:\n\n* Adults aged 18 years or older (19 years or older in the Republic of Korea).\n* Able to understand, sign, and provide written informed consent.\n* Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.\n* At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* Documented EGFR mutation determined by tumor tissue or liquid biopsy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Able to swallow oral capsules and comply with study procedures.\n* Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit.\n* No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator.\n* Participants must meet the disease-specific eligibility criteria for one of the following study groups:\n\n  * Phase 1a\n\n    * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations.\n    * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort A\n\n    * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib).\n  * Phase 1b - Cohort B\n\n    * Treatment-naïve NSCLC with common EGFR mutations.\n  * Phase 1b - Cohort C\n\n    * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort D\n\n    * Treatment-naïve NSCLC with atypical EGFR mutations.\n\nExclusion Criteria:\n\n* Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n* Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.\n* Pregnant or breastfeeding, or planning to become pregnant during the study.\n* NSCLC with an EGFR or HER2 exon 20 insertion mutation.\n* Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured.\n* Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria.\n* Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.\n* Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment.\n* Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period.\n* Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery.\n* Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy.\n* Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible.\n* Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit.\n* Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval.\n* History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis.\n* Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment.\n* Known allergy or hypersensitivity to VRN110755 or any of its components.\n* Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.\n* Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications.\n* For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.",{"count":267,"type":21},315,[269,64],"PHASE1","This first-in-human, Phase 1\u002F2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).\n\nThe study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.",[272],"EGFR-Mutant Non-Small Cell Lung Cancer",[180,274,275,276,277,278,279],"EGFR","Epidermal Growth Factor Receptor","Non-Small Cell Lung Cancer","EGFR Mutation","C797S","EGFR Tyrosine Kinase Inhibitor Resistance","2026-07-09",{"date":44,"type":45},{"date":283,"type":45},"2024-03-26",{"date":285,"type":21},"2029-01-01",{"name":287,"class":52},"Voronoi, Inc",29,{"id":290,"slug":4,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":295,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100053847","NCT07169279","Interventional Study of Infigratinib in Children \u003C 3 Years Old With Achondroplasia (ACH)","Phase 2b, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, Preceded by a Single Ascending Dose Portion and a Phase 2 Open-Label Portion, to Evaluate the Safety and Efficacy of Oral Infigratinib in Infants and Young Children With Achondroplasia","Inclusion Criteria:\n\n* Diagnosis of ACH confirmed by genetic testing. If prospective participants had prior genetic testing, the diagnosis must be confirmed by a report from a certified laboratory, documenting the specific mutation.\n* Age 0 to 32 months (2 years and 8 months) at screening.\n* Signed informed consent, which must be obtained from each participant's parent(s) or legal guardian.\n* Parent(s)\u002FGuardian(s) willing and able to attend all study visits and comply with all study requirements.\n* Parent(s)\u002FGuardian(s) willing and able to comply with the routine care of the study participants according to local guidance for the management of infants and young children with ACH.\n* Able to swallow age-appropriate oral medication.\n* In participants \\\u003C1 year old, be compliant with recommended vitamin D supplementation of 5 10 μg\u002Fday or higher (or as recommended by country specific guidelines).\n\nExclusion Criteria:\n\n* Participants who have hypochondroplasia or diagnosis of genetic condition other than ACH, or any clinical condition that can affect growth.\n* Gestational age at birth \\\u003C37 weeks and\u002For birth weight \\\u003C2500 grams.\n* Gastroesophageal reflux disease requiring prolonged treatment (\\>1 week) with prohibited medications.\n* Evidence of cervicomedullary compression, as defined by an Achondroplasia Foramen Magnum Score (AFMS) 4, symptomatic or asymptomatic, diagnosed during MRI done at screening or a previous MRI done at any time if the participant had not undergone decompression surgery.\n* History of fracture of a long bone or spine within 6 months prior to screening.\n* Any other significant concurrent disease or condition that, in the view of the investigator and\u002For sponsor, would confound assessment of efficacy or safety of infigratinib and\u002For would require treatment with a prohibited medication (per protocol), and\u002For would place the participant at high risk for poor treatment compliance or for failure to complete the study.\n* Having received or planning to receive treatment with any other investigational or approved product for the treatment of ACH or short stature, including (but not limited to) r-hGH, IGF-1, CNP analog, FGF ligand trap, or treatment targeting FGFR inhibition at any time.\n* Regular long-term (\\>3 weeks; more than twice\u002Fyear) treatment with supraphysiologic doses of glucocorticoid therapy (ie, \\>15 mg\u002Fm2\u002Fday of hydrocortisone or equivalent) or treatment with glucocorticoids at anti-inflammatory doses (for over 3 weeks within 6 months of the screening visit. NOTE: Low-dose topical, inhaled, or intranasal corticosteroids are acceptable.\n* Significant abnormality in screening laboratory results,\n* Allergy or hypersensitivity to any components of the study drug.","0 Years","32 Months",{"count":298,"type":21},77,[64],"This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \\\u003C 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \\\u003C 3 years old with ACH at the selected dose.",[302],"Achondroplasia",[304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326],"skeletal dysplasia","endochondral ossification","achondroplasia","ACH","Shortened proximal limbs","fibroblast growth factor receptor 3","FGFR3","disproportionate short stature","quality of life","dwarfism","bone diseases","musculoskeletal diseases","osteochondrodysplasia","functional abilities","annualized growth velocity","annualized height velocity","growth","growth disorder","congenital","AHV","AGV","infant and toddler","endochondral bone formation",{"date":44,"type":45},{"date":329,"type":45},"2025-11-19",{"date":331,"type":21},"2032-03",{"name":333,"class":52},"QED Therapeutics, a BridgeBio company",12,{"id":336,"slug":4,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100054172","NCT06726148","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPatients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":343,"type":21},280,[269,64],"Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization\u002Frecommended dose for future studies.\n\nPhase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[347,348,349],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors","Extensive-stage Small Cell Lung Cancer",[351,352,353,354,355,356],"ECI830","Ribociclib","Fulvestrant","Breast cancer","CCNE1 amplification","Small cell lung cancer",{"date":44,"type":45},{"date":359,"type":45},"2025-04-03",{"date":361,"type":21},"2028-09-25",{"name":363,"class":52},"Novartis Pharmaceuticals",33,{"id":366,"slug":4,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":16,"minAge":372,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":376,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":388,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":398},"100053812","NCT07697612","Durian Consumption in Adults With Type 2 Diabetes Mellitus","Durian Consumption on Human Microbiome and Metabolome in Adults With Type 2 Diabetes Mellitus (DURIOME-T2D)","DURIOME-T2D","Inclusion Criteria:\n\n1. Age 21 to 70 years.\n2. Diagnosis of type 2 diabetes mellitus.\n3. Agrees to consume durian for 2 weeks.\n4. Body mass index 25 to 40 kg\u002Fm².\n\nExclusion Criteria:\n\n1. Known or suspected intolerance or allergy to durian.\n2. Known skin reaction to adhesives used in a continuous glucose sensor.\n3. Uncontrolled diabetes (HbA1c greater than 8.5%).\n4. Severe hypertriglyceridemia (triglycerides greater than 4.5 mmol\u002FL).\n5. Smoking.\n6. Previous gastrointestinal surgeries, including cholecystectomy, gastrectomy, bariatric surgery, or colectomy.\n7. Inflammatory bowel disease.\n8. Glomerular filtration rate less than 30 mL\u002Fmin.\n9. ALT greater than 3 times upper limit of normal.\n10. AST greater than 3 times upper limit of normal.\n11. Liver cirrhosis.\n12. Significant alcohol consumption, defined as more than 20 g\u002Fday for women and more than 30 g\u002Fday for men.\n13. Pregnant, breastfeeding, or intending to conceive during the study.\n14. Current hemorrhoids or piles causing rectal bleeding during stool passage.\n15. Systemic steroid use.\n16. Insulin use.\n17. Weight loss medications, including GLP-1 receptor agonists, orlistat, or phentermine.\n18. Antibiotic, prebiotic, probiotic, vitamin C, or traditional Chinese medicine use in the last 1 month.\n19. Uncontrolled thyroid disease.\n20. Any factor likely to limit adherence to study protocol, including dementia, substance abuse, poor appointment adherence, or family concerns regarding participation","21 Years","70 Years",{"count":375,"type":21},40,[377],"NA","This single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Forty adults with T2DM will undergo a pre-durian phase, a durian consumption phase, and a post-durian phase, each lasting 10 to 14 days. Participants will attend five visits at Singapore General Hospital for clinical assessments, continuous glucose monitoring, fasting blood collection, stool sample collection, and dietary and stool record submission. The study aims to determine whether durian consumption alters microbiome and metabolomic profiles and whether it affects glycemic measures in adults with T2DM.",[380],"Type 2 Diabetes",[382,383,384,385,386,387],"Durian","Gut Microbiome","Metabolome","Continuous Glucose Monitoring","Precision Nutrition","Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-07-06",{"date":44,"type":45},{"date":392,"type":21},"2026-08",{"date":394,"type":21},"2027-12",{"name":396,"class":397},"Singapore General Hospital","OTHER",1,{"id":400,"slug":4,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":407,"briefSummary":408,"conditions":409,"keywords":416,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":465},"100607241","NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.",{"count":406,"type":21},480,[24],"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[410,411,412,413,414,415],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[417,418,419,420,421,422,423,424,425,180,426,427,428,429,430,431,432,433,434,182,274,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","2026-07-01",{"date":458,"type":45},"2026-07-02",{"date":460,"type":45},"2025-12-17",{"date":462,"type":21},"2030-12",{"name":464,"class":52},"ArriVent BioPharma, Inc.",78,{"id":467,"slug":4,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":482,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100605991","NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.",{"count":473,"type":21},180,[269,64],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[477,478,479,480,481],"Cervical Squamous Cell Carcinoma","Squamous Non-small-cell Lung Cancer","Colorectal Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[483,484,485,486,487],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion",{"date":458,"type":45},{"date":490,"type":45},"2025-08-26",{"date":492,"type":21},"2029-10-04",{"name":494,"class":52},"Alentis Therapeutics AG",41,{"id":497,"slug":4,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":502,"maxAge":244,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":364},"100597406","NCT07058077","A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)","An Operationally Seamless Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia","Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results\n* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg\u002FdL\n* Is receiving either:\n\n  * An optimized daily dose of statin (± nonstatin LLT)\n  * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative\n* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH\n* Has a history of nephrotic syndrome\n* Has any clinically significant malabsorption condition based on investigator assessment\n* Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors without adequate washout","6 Years",{"count":504,"type":21},153,[64,24],"This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.\n\nThe goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.",[508],"Heterozygous Familial Hypercholesterolemia (HeFH)",{"date":458,"type":45},{"date":511,"type":45},"2025-08-21",{"date":513,"type":21},"2037-01-23",{"name":96,"class":52},{"id":516,"slug":4,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":522,"minAge":17,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":542},"100579031","NCT06819007","Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01\u002FENGOT-ov89\u002FGEICO144- O\u002FGOG-3112\u002FAPGOT-OV13)","DO-01","Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed FIGO Stage III or IV.\n5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines1 by prospective central testing.\n\n   \\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \\[IHC 3+\u002F2+\u002F1+\\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.\n6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.\n\n   \\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.\n7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.\n8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:\n\n   * HRD negative\n   * HRD positive with SD as best response after platinum\n   * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea\n   * HRD tested, but inconclusive\n   * HRD positive but safety concern (safety concern to be specified).\n4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.\n5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea,\n6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.\n8. Evidence of active or ongoing bowel obstruction.\n9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).\n\n   Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n10. Has a corrected QT interval prolongation to \\>480 msec based on average of the Screening triplicate 12-lead ECG.\n11. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.","FEMALE",{"count":524,"type":21},582,[24],"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+\u002F2+\u002F1+) advanced high-grade epithelial ovarian cancer.",[528],"Ovarian Cancer",[530,531,532,533,534],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":458,"type":45},{"date":537,"type":45},"2025-03-19",{"date":539,"type":21},"2032-01-31",{"name":541,"class":52},"Daiichi Sankyo",208,{"id":544,"slug":4,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":549,"sex":16,"minAge":17,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":375},"100546905","NCT06401044","A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease","A Phase 1\u002F2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects With Moderate-to-Severe Active Thyroid Eye Disease","Inclusion criteria for Part A\u002FPhase 1 only:\n\n* Participant has provided informed consent before initiation of any study-specific activities\u002Fprocedures.\n* Male or female aged 18 to 55 years (Part A).\n* Female participants must be of non-childbearing potential.\n* Body mass index (BMI) between 18 and 30 kg\u002Fm\\^2, inclusive, at screening.\n* The participant has adequate venous access and can receive intravenous (IV) therapy.\n* The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.\n* Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic Japanese who were born in Japan; Hold a Japanese passport or identity papers; Have lived outside Japan for less than 10 years at the time of screening and lifestyle including diet has not changed significantly since leaving Japan.\n\nInclusion criteria for Part B\u002FPhase 2 only:\n\n* Male or female aged 18 to 65 years.\n* Moderate-to-severe active TED.\n* The participant had onset of active TED within 15 months prior to baseline.\n* Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline.\n* Proptosis ≥18mm in the study eye at baseline.\n* Participants with baseline subjective binocular diplopia score \\>0.\n* Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery\u002Firradiation during the trial.\n\nExclusion criteria for Part A and Part B:\n\n* Malignant condition in the past 12 months or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study.\n* Active liver or kidney disfunction at screening.\n* Positive test for hepatitis B\u002FC or Human immunodeficiency virus (HIV) serology at screening.\n* Glycated hemoglobin (HbA1c) \\> 6.5% and\u002For fasting glucose levels\\> 126 mg\u002FdL (\\> 7 mmol\u002FL) at screening.\n* Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat injection related reactions or short course of steroid for asthma control.\n* Known hypersensitivity to teprotumumab or any other monoclonal antibody products.\n* History of substance abuse within 12 months before screening.\n* Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing.\n\nExclusion criteria for PartA\u002FPhase 1 only\n\n• Blood pressure or ECG abnormalities at screening.\n\nExclusion criteria for Part B\u002FPhase 2 only:\n\n* Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.\n* Use of teprotumumab or any other IGF-1R inhibitor.\n* Prior orbital irradiation or decompression in the study eye.\n* History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.",true,"65 Years",{"count":552,"type":21},88,[269,64],"The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.",[556],"Thyroid Eye Disease",[558,556,559],"AMG 732","TED",{"date":458,"type":45},{"date":562,"type":45},"2024-05-30",{"date":564,"type":21},"2027-08-13",{"name":566,"class":52},"Amgen",{"id":568,"slug":4,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":592},"100600503","NCT07098338","A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)","An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)","LIBRA","Inclusion Criteria for All Sub-studies:\n\n* Participant must be ≥ 18 years of age at the time of signing the ICF\n* WHO\u002FECOG performance status of 0 or 1\n* At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n* Adequate bone marrow and organ function\n* Life expectancy ≥ 12 weeks\n* Provision of acceptable tumour tissue\n\nSpecific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:\n\n* Histologically or cytologically documented advanced or metastatic NSCLC\n* PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)\n* Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)\n\nSpecific Inclusion Criteria for Sub-Study 3:\n\n* Histologically or cytologically documented advanced or metastatic non-squamous NSCLC\n* Documented positive AGA and had progressed on prior targeted therapy\n\nExclusion Criteria for All Sub-studies:\n\n* As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol\n* Active or prior documented autoimmune or inflammatory disorders\n* Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.\n* Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3\n* Unstable brain metastases\n* History of another primary malignancy.\n* Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.\n* Uncontrolled or significant cardiac disease\n* Receipt of prior systemic chemotherapy\u002Fchemoradiation\u002Fimmunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.\n* Prior exposure to immune-mediated therapy\n* History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation\n* Any concurrent anti-cancer treatment.\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.",{"count":575,"type":21},278,[64],"This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.",[276],[580,581,582,583],"Non-Small Cell Lung Cancer(NSCLC)","Antibody-Drug Conjugates (ADCs)","T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT)","Programmed death-ligand 1 (PD-L1)","2026-06-30",{"date":456,"type":45},{"date":587,"type":45},"2025-08-07",{"date":589,"type":21},"2029-04-06",{"name":591,"class":52},"AstraZeneca",83,{"id":594,"slug":4,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":607,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":617},"100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":600,"type":21},2400,[24],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[604,605,606],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[608,609,610],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":458,"type":45},{"date":613,"type":45},"2025-06-30",{"date":615,"type":21},"2034-12-29",{"name":96,"class":52},310,{"id":619,"slug":4,"hasResults":11,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":627,"phases":4,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":635,"locationsCount":637},"100550119","NCT06442930","EXtubation Related Complications - the EXTUBE Study (EXTUBE)","EXtubation Related Complications - an International Observational Study To Understand the Impact and BEst Practices in the Operating Room and Intensive Care Unit - the EXTUBE Study","EXTUBE","Inclusion Criteria:\n\n* Adult patients (≥18 years old)\n* Undergoing extubation of an endotracheal tube (including index extubation and re-extubations) after general anesthesia in the OR, out of OR anesthesia location or ICU\n* Undergoing extubation during the specified enrollment window\n\nExclusion Criteria:\n\n* Patients will be excluded if the extubation is performed in the context of withdrawal of life support measures,\n* Patients will be excluded if the extubation is performed for tracheostomy decannulation\n\nFor each patient who is not included, reasons for exclusion will be reported.",{"count":626,"type":21},3000,"OBSERVATIONAL","EXTUBE is an international, multicentre, prospective cohort study evaluating the incidence, risk factors, and outcomes of extubation-related complications and describing clinical practices related to extubation after general anesthesia or after critical illness in the operating room (OR), out of OR anesthesia location or intensive care unit (ICU).",[630],"Extubation",{"date":458,"type":45},{"date":633,"type":45},"2025-04-14",{"date":394,"type":21},{"name":636,"class":397},"University Health Network, Toronto",32,{"id":639,"slug":4,"hasResults":11,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":552},"100518340","NCT06029270","Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer","A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent\u002FMetastatic Nasopharyngeal Carcinoma (REMAIN)","Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and\u002For is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics:\n\n  * Tumor showing (histological\u002Fcytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or\n  * A known history of detectable plasma EBV DNA (via a polymerase chain reaction \\[PCR\\]-based assay) at any time point since the initial diagnosis of NPC.\n* Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.\n\n  * Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.\n  * CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated).\n  * Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional.\n  * Symptomatic and active brain metastases and\u002For leptomeningeal metastasis on CT and\u002For MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord\u002Fcauda compression who are clinically stable for \\>= 2 months prior to registration and have discontinued systemic steroids therapy (\\> 10 mg\u002Fday prednisone or equivalent) \\> 4 weeks prior to registration are eligible.\n  * Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and\u002For significant vasogenic edema on radiological imaging.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* Absolute neutrophil count (ANC) \\>= 1500 cells\u002Fmm\\^3.\n* Platelets \\>= 100,000 cells\u002Fmm\\^3.\n* Hemoglobin (Hgb) \\>= 8.0 g\u002FdL (Transfusion is accepted. Erythropoietin dependency not accepted.).\n* Total bilirubin =\\\u003C 1.5 × institutional upper limit of normal (ULN) or direct bilirubin =\\\u003C ULN for patients with total bilirubin levels \\> 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level =\\\u003C 3 × ULN may be enrolled.\n* Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 × ULN (=\\\u003C 5 × ULN for patients with liver metastases).\n* Serum creatinine =\\\u003C 1.5 × ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation \\>= 30 mL\u002Fmin for patients with serum creatinine levels \\> 1.5 × ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL\u002Fmin, for whom carboplatin should be used instead of cisplatin. CrCl must be \\> 50 mL\u002Fmin for cisplatin to be used.\n* Albumin-adjusted calcium level based on corrected calcium equation =\\\u003C 1.5 × ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment).\n* No prior systemic treatment of palliative intent for recurrent\u002Fmetastatic (R\u002FM) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence.\n* No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n* The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and\u002For induction, concurrent, or adjuvant chemotherapy and recurrence must be ˃ 6 months.\n* Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed.\n* No prior palliative RT within 30 days prior to registration unless the irradiated site(s) are not the target lesions. The irradiated site(s) also must not be the only sites of measurable recurrent disease.\n* No major surgical procedures within 30 days prior to registration.\n* No history of unstable angina requiring hospitalization within the last 6 months.\n* No history of myocardial infarction within the last 6 months.\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III\u002FIV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction \\\u003C 50% must be stably controlled with medication in the opinion of the treating physician, in consultation with a cardiologist if appropriate.\n* No prior history of myocarditis.\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments at the time of study registration.\n* No history of (non-infectious) pneumonitis that required steroids or current pneumonitis requiring steroids and\u002For immunosuppressive therapy, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), or idiopathic pneumonitis.\n* No history of multi-drug resistant mycobacterium tuberculosis (TB) or active TB, as defined by systemic treatment received =\\\u003C 2 years prior to registration. Note: Patients who had a history of treated TB ˃ 2 years prior to registration are allowed.\n* No prior solid organ transplant or bone marrow transplant.\n* No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids (\\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid premedication for the prophylaxis of CT contrast-related allergies is allowed. The use of dexamethasone as an anti-emetic premedication prior to chemotherapy is also allowed.\n* No active autoimmune disease requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These may include (but not limited to) patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, autoimmune hepatitis, glomerulonephritis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome.\n\n  * Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; alopecia; and\u002For psoriasis not requiring systemic treatment. Conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* No prior live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines that are approved by the local drug regulatory authority of the participating region are allowed.\n* No known history of grade 3-4 allergic reaction or hypersensitivity reaction to cisplatin, carboplatin, or gemcitabine.\n* No known history of grade 4 hypersensitivity (or infusion) reaction to any monoclonal antibody. Patients who had prior grade 3 hypersensitivity (or infusion) reaction but could tolerate resumption of the antibody treatment after appropriate pre-medication are eligible.\n* PRIOR TO STEP 2 REGISTRATION:\n* Collection of plasma EBV DNA at baseline is mandatory for all patients prior to Step 2 registration and induction treatment.\n\n  * Note: Submission of the baseline sample will be batch shipped.\n* PRIOR TO STEP 3 REGISTRATION\u002FRANDOMIZATION: PATIENTS WITHOUT PROGRESSIVE DISEASE (PD) ONLY:\n* All patients must have received minimum of 3 cycles, and up to a maximum of 6 cycles of induction treatment within 20 weeks from cycle 1, day 1 of induction treatment (i.e., patients must have completed all induction treatment within 20 weeks from cycle 1 day 1, including the treatment breaks). Patients must have completed 6 cycles of induction treatment, except in the following circumstances:\n\n  * Significant dose delays as a result of treatment-related toxicities.\n  * Intercurrent illness(s), that rendered the patient unable to continue induction treatment.\n  * Note: If a patient received \\\u003C 6 cycles of induction treatment for reasons other than the above circumstances, they will not be eligible for randomization.\n* A CT scan within 30 days prior to Step 3 registration\u002Frandomization is required. If the most recent scan performed is not within this time frame, a repeat scan is required to assess response.\n* Did not meet any criteria that result in permanent discontinuation of study treatment during induction treatment phase.\n* Must meet the criteria for starting\u002Fresuming a new cycle of maintenance treatment.\n* Did not experience any nivolumab-related autoimmune toxicities that would result in permanent discontinuation of nivolumab during the induction treatment phase.\n* Collection of the plasma EBV DNA post-induction treatment is mandatory.\n\n  * Note: Submission of the post-induction sample will be batch shipped.",{"count":195,"type":21},[64],"This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.",[648,649,650],"Metastatic Nasopharyngeal Carcinoma","Recurrent Nasopharyngeal Carcinoma","Stage IV Nasopharyngeal Carcinoma AJCC v8",{"date":456,"type":45},{"date":653,"type":45},"2024-07-15",{"date":655,"type":21},"2029-04-30",{"name":657,"class":658},"National Cancer Institute (NCI)","NIH",{"id":660,"slug":4,"hasResults":11,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":22,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":679},"100446879","NCT05099172","First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and\u002For Human Epidermal Growth Factor Receptor 2 (HER2)","An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and\u002For HER2 Mutation","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.\n\nNote: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.\n\n* Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.\n* Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.\n* Documented activating EGFR and\u002For HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \\[US\\] sites) or an equally accredited (outside of the US) local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.\n  2. Platelets ≥ 100 × 10\\^9 cells\u002FL.\n  3. Absolute neutrophil count ≥ 1.5 ×10\\^9 cells\u002FL. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.\n* Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:\n\n  a. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin per 1.73 m\\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.\n* Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).\n  2. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).\n\nExclusion Criteria:\n\n* Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n* Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.\n* Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.\n* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n* Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).\n* History of spinal cord compression or brain metastases with the following exceptions:\n\n  1. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.\n  2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion\u002FExtension (with the exception of Group G and Group H) if all of the following criteria are met:\n\n     * there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n     * Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.\n  3. Participants with history of spinal cord compression \\>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.\n  4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg\u002Fday dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.\n* History of congestive heart failure (CHF) Class \\>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec).\n* Participants with:\n\n  1. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells\u002FuL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies\u002FmL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months\n  2. Active Hepatitis B infection (positive for Hepatitis B surface antigen \\[HbsAg\\]) and Hepatitis B virus \\[HBV\\] DNA).\n  3. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).\n\n     NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n* Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.",{"count":666,"type":21},400,[269,64],"Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.\n\nEpidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and\u002For HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and\u002For HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.\n\nThe main purpose of this study is to learn:\n\nEscalation, Backfill, and Expansion Part:\n\n* How safe is BAY2927088 for the participants?\n* What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants?\n* How does BAY2927088 move into, through, and out of the bodies of the participants?\n\nFor this, the researchers will measure the followings:\n\n* The number of participants with medical problems, also called adverse events and serious adverse events, and their severity\n* The number of participants who discontinue study treatment due to an adverse event.\n* The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088\n* Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level\n* The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088\n* The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part\n* How well does BAY2927088 work in participants?\n\nFor this, the researchers will measure the following:\n\n• Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor.\n\nThis study has 4 parts:\n\n* The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive.\n* The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part.\n* The expansion part aims to determine the dose of BAY2927088 to be tested in further studies.\n* The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well.\n\nThe participants in this study will take the study treatment BAY2927088 in 3-week periods called \"cycles\". They will in general take BAY2927088 once or twice daily as a liquid\u002Ftablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle.\n\nDuring the study, the study team will:\n\n* take blood and urine samples,\n* check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans,\n* check the participants' overall health and heart health,\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is considered \"serious\" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.",[670,277,671],"Advanced Non-small Cell Lung Cancer","HER2 Mutation",{"date":456,"type":45},{"date":674,"type":45},"2021-10-25",{"date":676,"type":21},"2029-06-29",{"name":678,"class":52},"Bayer",94,{"id":681,"slug":4,"hasResults":11,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":4,"eligibilityCriteria":685,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":341,"enrollmentInfo":686,"targetDuration":4,"studyType":22,"phases":688,"briefSummary":689,"conditions":690,"keywords":691,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":703},"100639848","NCT07604571","Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer","An Open-label, Multi-center, Phase I\u002FIb Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n\n  * Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):\n\nHR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4\u002F6 inhibitor and at least one additional line of systemic therapy in the unresectable\u002Fmetastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.\n\n\\- Dose expansion of IEV407 in combination with fulvestrant: HR+\u002FHER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4\u002F6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable\u002Fmetastatic setting. Prior cytotoxic chemotherapy and\u002For antibody-drug conjugate therapies in the unresectable\u002Fmetastatic setting are not allowed.\n\nExclusion Criteria:\n\n* Patients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Concurrent use of hormone replacement therapy.\n* Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n* For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":687,"type":21},194,[269],"The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.",[347],[692,693,694,695],"IEV407","HR+\u002FHER2- advanced breast cancer","letrozole","fulvestrant","2026-06-29",{"date":584,"type":45},{"date":699,"type":45},"2026-05-28",{"date":701,"type":21},"2032-06-08",{"name":363,"class":52},3,""]