[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bristol-Myers Squibb\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":623},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,112,0,25,[9,41,71,103,130,160,183,204,226,249,274,299,319,344,363,393,431,459,484,500,509,531,550,573,601],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053295",false,"NCT07011732","A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease","Inclusion Criteria\n\n\\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42\u002F40 ratio in CSF, pTau181\u002FAβ42 ratio in CSF or pTau217\u002FAβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.\n\nii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.\n\nB. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:\n\n* Amyloid PET.\n* Aβ42\u002F40 ratio or pTau181\u002FAβ42 ratio in CSF using an HA-authorized diagnostic assay.\n\n  * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).\n  * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:\n\n    i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.\n  * History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).\n  * AD participants are required to have NPI\u002FNPI-NH Agitation\u002FAggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).\n  * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).\n\nExclusion Criteria\n\n\\- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.\n\nii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.\n\niv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and\u002For C-SSR.\n\n\\- Prior\u002FConcomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).\n\nA. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.\n\nB. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).\n\nC. Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","55 Years","90 Years",{"count":20,"type":21},426,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.",[27],"Alzheimer Disease","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2025-07-10",{"date":36,"type":21},"2028-12-08",{"name":38,"class":39},"Bristol-Myers Squibb","INDUSTRY",158,{"id":42,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100053687","NCT06122779","Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435\u002FMYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)","A Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435\u002FMYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)","AURORA-HFpEF","Inclusion Criteria\n\n\\- Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability.\n\nExclusion Criteria\n\n* Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative\u002Fstorage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","40 Years","85 Years",{"count":51,"type":21},208,[53],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435\u002FMYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).",[56],"Heart Failure",[58,59,60,61,62,63],"BMS-986435","MYK-224","Pharmacokinetics","Pharmacodynamics","Safety","HFpEF",{"date":31,"type":32},{"date":66,"type":32},"2023-11-07",{"date":68,"type":21},"2026-12-14",{"name":38,"class":39},117,{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100626882","NCT07441408","Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis","An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis","Inclusion Criteria:\n\n\\- Participants must have completed participation in either IM027068 or IM0271015 (defined as receiving study intervention (IMP) until completion of EOT visit).\n\nExclusion Criteria:\n\n* Clinically significant AE that resulted in discontinuation or interruption of IMP (Investigational Medicinal Product) in IM027068 or IM0271015 without reinitiation of IMP.\n* Exhibit symptoms of heart failure at rest.\n* History of lung reduction surgery or lung transplant. Note: Being on the transplantation list is allowed.\n* Participants with known PAH (Pulmonary Arterial Hypertension) who has been on single drug therapy that now requires multi-drug therapy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":78,"type":21},2277,[24],"The purpose of this study is to evaluate the long-term safety and tolerability of Admilparant in participants who completed participation in parent studies IM027-068 (for idiopathic pulmonary fibrosis (IPF)) and IM027-1015 (for progressive pulmonary fibrosis (PPF)).",[82],"Pulmonary Fibrosis",[84,85,86,87,88,89,90,91,92],"LPA1 receptor antagonist","Idiopathic pulmonary fibrosis","Progressive pulmonary fibrosis","Long-term extension","IPF","PPF","IM027068","IM0271015","Follow up","NOT_YET_RECRUITING","2026-07-01",{"date":96,"type":32},"2026-07-02",{"date":98,"type":21},"2026-12-16",{"date":100,"type":21},"2030-03-30",{"name":38,"class":39},275,{"id":104,"slug":4,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100592715","NCT06997029","A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4\u002F6 Inhibitor Pre-treated Advanced Breast Cancer","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","18 Years",{"count":111,"type":21},234,[113],"PHASE1","The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4\u002F6 inhibitor pre-treated advanced breast cancer.",[116,117,118],"Advanced Solid Tumor","Advanced Breast Cancer","Advanced Ovarian Cancer",[120,121,122],"cancer","oncology","solid tumor",{"date":96,"type":32},{"date":125,"type":32},"2025-08-01",{"date":127,"type":21},"2028-12-14",{"name":38,"class":39},21,{"id":131,"slug":4,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100574860","NCT06764771","A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors","A Phase 1\u002F1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.\n* Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).\n* Parts 2A, 1D, 2D: ccRCC.\n\n  i) Part 1B: solid tumors with KRAS G12C mutation.\n\nii) Part 2B: NSCLC with KRAS G12C mutation.\n\niii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.\n\n* Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.\n* Participants must have measurable disease per RECIST v1.1.\n\nExclusion Criteria:\n\n* Untreated central nervous system (CNS) metastases.\n* Leptomeningeal metastasis (carcinomatous meningitis).\n* Impaired cardiac function or clinically significant cardiac disease.\n* For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.\n\n  i) History of pneumonitis or interstitial lung disease (ILD).\n\nii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).\n\n\\- Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":137,"type":21},437,[113],"This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.",[141],"Advanced Malignant Tumors",[143,144,145,146,147,148,149,150,151,152],"Colorectal Cancer","CRC","Renal Cell Carcinoma","RCC","Non-Small Cell Lung Cancer","NSCLC","Cancer","Oncology","Phase 1","Solid Tumor",{"date":96,"type":32},{"date":155,"type":32},"2025-03-25",{"date":157,"type":21},"2027-10-15",{"name":38,"class":39},8,{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},"100572244","NCT06730750","A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed, advanced, unresectable\u002Fmetastatic solid tumor measurable by RECIST v1.1.\n* CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:\n\n  i) Locally advanced\u002Fmetastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and\u002For oxaliplatin (if available and not contraindicated).\n* NSCLC: Part 2A-NSCLC\u002FGC, 2L+ NSCLC:\n\n  i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.\n\nii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.\n\n\\- GC: Part 2A-NSCLC\u002FGC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).\n\nii) ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n* History of anaphylactic reactions to irinotecan and\u002For bevacizumab.\n* Previously received therapy targeting CEACAM5.\n* Grade ≥3 ILD\u002Fpneumonitis.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":167,"type":21},360,[113,53],"This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.",[171],"Advanced Solid Tumors",[173,174,175],"Colorectal Cancer (CRC)","Non-small Cell Lung cancer (NSCLC)","Gastric Cancer (GC)",{"date":96,"type":32},{"date":178,"type":32},"2025-02-12",{"date":180,"type":21},"2029-12-09",{"name":38,"class":39},6,{"id":184,"slug":4,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100354763","NCT03899155","Pan Tumor Rollover Study","Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies","Inclusion Criteria\n\n* Signed Written Informed Consent.\n* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.\n* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.\n* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.\n\nExclusion Criteria\n\n* Participant is not eligible for study treatment per the Parent Study eligibility criteria.\n* Participants not receiving clinical benefit as assessed by the Investigator.\n* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.\n* Other protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":190,"type":21},1500,[53],"Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.",[149],[195,196],"Rollover","pan-tumor",{"date":96,"type":32},{"date":199,"type":32},"2019-08-09",{"date":201,"type":21},"2029-08-25",{"name":38,"class":39},399,{"id":205,"slug":4,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":210,"sex":16,"minAge":109,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100610379","NCT07226817","A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants","A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulation (Part 3) in Healthy Adult Participants","Inclusion Criteria\n\n* Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg\u002Fm2, inclusive\n* Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments\n* Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment\n* Other protocol-defined Inclusion\u002FExclusion criteria apply",true,"60 Years",{"count":213,"type":21},140,[113],"This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.",[217],"Healthy Volunteers","2026-06-30",{"date":94,"type":32},{"date":221,"type":32},"2025-11-12",{"date":223,"type":21},"2026-12-17",{"name":38,"class":39},1,{"id":227,"slug":4,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},"100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":233,"type":21},650,[24],"The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[27,237],"Agitation",[237,239,240,241],"Alzheimer disease","KarXT","KarX-EC",{"date":94,"type":32},{"date":244,"type":32},"2025-12-02",{"date":246,"type":21},"2029-07-20",{"name":38,"class":39},256,{"id":250,"slug":4,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},"100563601","NCT06618287","A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors","A Phase 1\u002F2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participants must have a life expectancy of at least 3 months at the time of the first dose.\n* Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed\n* Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC.\n* Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC.\n* Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO\u002FCAP criteria, based on the most recently analyzed biopsy or another pathology specimen.\n* Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent.\n\nExclusion Criteria\n\n* Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.\n* Participants with known mutations in EGFR will be excluded (Group A,B and E).\n* Participants must not have a history of serious recurrent infections.\n* Participants must not have a history of severe heart disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":256,"type":21},416,[113,53],"The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.",[260,261],"Lung Cancer","Breast Cancer",[263,264,265,266],"Non-Small Cell Lung Cancer (NSCLC)","Epidermal Growth Factor Receptor mutated (EGFRmt)","Epidermal Growth Factor Receptor wild-type (EGFRwt)","Triple-negative breast cancer (TNBC)",{"date":94,"type":32},{"date":269,"type":32},"2025-02-04",{"date":271,"type":21},"2031-02-26",{"name":38,"class":39},64,{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":280,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100614834","NCT07284745","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.","5 Years","17 Years",{"count":283,"type":21},176,[24],"The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.",[287],"Irritability Associated With Autism Spectrum Disorder",[289,290],"Cobenfy","Autism Spectrum Disorder","2026-06-29",{"date":218,"type":32},{"date":294,"type":21},"2026-09-11",{"date":296,"type":21},"2029-07-05",{"name":38,"class":39},40,{"id":300,"slug":4,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":305,"maxAge":281,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100615127","NCT07288567","A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)","A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)","Inclusion Criteria:\n\n* Diagnosis of schizophrenia as defined by the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) and experiencing symptoms of psychosis at screening (Visit 1).\n* PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).\n* Participant has a CGI-S score of ≥ 4 at screening (Visit 1) and randomization (Visit 2).\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.\n* History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]). Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.\n* Any neurological disorder, except for Tourette's Syndrome.\n* Participants who have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","13 Years",{"count":307,"type":21},166,[24],"The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.",[311],"Schizophrenia",{"date":218,"type":32},{"date":314,"type":32},"2026-01-29",{"date":316,"type":21},"2029-12-18",{"name":38,"class":39},44,{"id":320,"slug":4,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100588940","NCT06947941","A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)","A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease","Inclusion Criteria:\n\n* Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).\n* Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup.\n* Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.\n* Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).\n\nExclusion Criteria:\n\n* Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.\n* Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.\n* Participants must not have certain safety concerns, including certain laboratory test irregularities.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":326,"type":21},325,[24],"The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.",[27,330],"Psychosis",[239,332,333,334,330,335,336],"Alzheimer's disease","Alzheimer's","Dementia","Alzheimer's disease psychosis","Alzheimer's disease psychosis with or without agitation",{"date":218,"type":32},{"date":339,"type":32},"2026-03-25",{"date":341,"type":21},"2028-03-20",{"name":38,"class":39},22,{"id":345,"slug":4,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},"100583934","NCT06882785","A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia","A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia","Inclusion Criteria\n\n* Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).\n* Participants must have a PANSS total score between 80 and 120, inclusive.\n* Participants must have a CGI-S score of ≥ 4.\n\nExclusion Criteria\n\n* Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.\n* Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.\n* Participants must not have any history or presence of clinically significant medical conditions.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":352,"type":21},250,[24],"The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia",[311],{"date":218,"type":32},{"date":358,"type":32},"2025-06-10",{"date":360,"type":21},"2029-08-23",{"name":38,"class":39},56,{"id":364,"slug":4,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":392},"100565753","NCT06646276","A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","Inclusion Criteria\n\n* Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).\n* Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.\n* Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system\n\nExclusion Criteria\n\n* Participants have already received certain types of treatment for extensive stage small cell lung cancer\n* Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":370,"type":21},530,[24],"The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.",[374],"Extensive-Stage Small Cell Lung Cancer",[376,377,374,378,379,380,381,382,383,384,385],"BMS-986489","BMS-986012","Etoposide","Carboplatin","Nivolumab","TIGOS","fucGM1","SCLC","ES-SCLC","atigotatug",{"date":218,"type":32},{"date":388,"type":32},"2025-02-25",{"date":390,"type":21},"2031-09-05",{"name":38,"class":39},183,{"id":394,"slug":4,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":415,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":430},"100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":400,"type":21},1109,[113,53],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[404,405,406,407,408,409,410,411,412,413,414],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[416,404,144,417,418,405,419,406,420,380,407,148,421,408,409,410,411,412,413,414,422,423],"BMS-986340","First-in-human","GEJ","HNSCC","MSS CRC","SCCHN","Docetaxel","Pumitamig",{"date":218,"type":32},{"date":426,"type":32},"2021-05-27",{"date":428,"type":21},"2031-08-31",{"name":38,"class":39},47,{"id":432,"slug":4,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":458},"100645238","NCT07680764","A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria\n\n* Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.\n* Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.\n* Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.\n* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria\n\n* Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.\n* Participants must not have prior treatment with immuno-oncology therapies.\n* Participants must not have untreated central nervous system (CNS) metastases.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":438,"type":21},160,[53],"The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)",[442,443],"Locally Advanced Non-Small Cell Lung Cancer (NSCLC)","Metastatic Non-Small Cell Lung Cancer (NSCLC)",[445,446,447,448,449,450],"Squamous Non-Small Cell Lung Cancer (NSCLC)","Non-squamous Non-Small Cell Lung Cancer (NSCLC)","Immunotherapy","Bispecific antibody","Imzokitug","Anti-CCR8 monoclonal antibody","2026-06-26",{"date":96,"type":32},{"date":454,"type":21},"2026-08-15",{"date":456,"type":21},"2030-09-15",{"name":38,"class":39},71,{"id":460,"slug":4,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},"100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":466,"type":21},850,[24],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[147],[148,471,472,473,474,475,476],"EGFR","First line","Izalontamab brengitecan","Osimertinib","ADC","IZABRIGHT-Lung02",{"date":96,"type":32},{"date":479,"type":21},"2026-09-30",{"date":481,"type":21},"2031-12-30",{"name":38,"class":39},180,{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":280,"maxAge":281,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":285,"conditions":492,"keywords":493,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":499},"100614915","NCT07285798","A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit\u002Fhyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history\u002Fpresence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion\u002FExclusion criteria may apply.",{"count":283,"type":21},[24],[287],[290],{"date":218,"type":32},{"date":294,"type":21},{"date":497,"type":21},"2029-08-04",{"name":38,"class":39},54,{"id":501,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":25,"conditions":504,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":508,"locationsCount":40},"100593845",{"count":20,"type":21},[24],[27],{"date":218,"type":32},{"date":34,"type":32},{"date":36,"type":21},{"name":38,"class":39},{"id":510,"slug":4,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":517,"phases":4,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100645182","NCT07679061","First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)","Prospective Observational Study of First-Line Nivolumab Plus Ipilimumab in Patients With Unresectable Hepatocellular Carcinoma in Japan (J-PROMISE)","Inclusion Criteria:\n\n* Participants aged ≥ 18 years at the time of consent\n* Participants with unresectable hepatocellular carcinoma (uHCC), defined as disease not eligible for curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies\n* Child-Pugh class A (total score 5-6)\n* Participants who have not received prior systemic drug therapy for uHCC\n\n  * Participants who relapsed more than 6 months after completion of postoperative adjuvant therapy are eligible\n  * Participants who received lenvatinib in combination with transarterial chemoembolization (TACE) are eligible if the treating physician determined they were eligible for TACE; participants are excluded if TACE eligibility at the time of lenvatinib initiation is unclear\n* Participants scheduled to initiate nivolumab plus ipilimumab combination therapy between March 1, 2026 and February 28, 2027\n\n  * Nivolumab plus ipilimumab combination therapy is defined as nivolumab 80 mg and ipilimumab 3 mg\u002Fkg administered intravenously every 3 weeks for 4 cycles, followed by nivolumab monotherapy at 240 mg every 2 weeks or 480 mg every 4 weeks\n* Participants who provide written informed consent prior to initiation of nivolumab plus ipilimumab therapy\n\nExclusion Criteria:\n\n* Known fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma\n* Prior liver transplant\n* ECOG performance status ≥ 3\n* Uncontrolled comorbidities despite treatment\n* Other advanced cancers requiring systemic therapy\n* Prior immuno-oncology treatment\n* Participation in interventional clinical trials at enrollment\n* Deemed unsuitable by investigator",{"count":516,"type":21},200,"OBSERVATIONAL","This study looks at how a combination of two medicines, nivolumab and ipilimumab, is used to treat people with advanced liver cancer that cannot be removed by surgery. The study will follow adults receiving this treatment in routine medical care in Japan to understand how safe it is, how well it works, and how it is used in standard clinical practice.",[520],"Unresectable Hepatocellular Carcinoma",[522],"Hepatocellular carcinoma; HCC; nivolumab; ipilimumab","2026-06-25",{"date":94,"type":32},{"date":526,"type":32},"2026-03-05",{"date":528,"type":21},"2028-02-29",{"name":38,"class":39},2,{"id":532,"slug":4,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":517,"phases":4,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":225},"100634603","NCT07541833","Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)","A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Cibenzoline in Japan (MANAGE-HCM)","Inclusion Criteria:\n\n• Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)-approved ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures.\n\n* Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:\n\n  * Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM).\n  * Has Left Ventricular Outflow Tract (LVOT) peak gradient ≥ 30 mmHg (resting, Valsalva maneuver, or post-exercise).\n* Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.\n* Participants who meet any of the following criteria:\n\n  * Participants who have previously received mavacamten continuously for ≥ 16 weeks\n  * Participants who are currently receiving mavacamten\n  * Participants who are scheduled to receive mavacamten\n* Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering.\n* At least 18 years of age at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients.\n* During pregnancy and in women of childbearing potential.\n* Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone\u002Fmisoprostol).\n* Severe hepatic impairment (Child-Pugh C).\n* Severe atrioventricular block or severe sinoatrial block.\n* Congestive heart failure.\n* Requiring dialysis.\n* Angle-closure glaucoma.\n* Tendency to urinary retention.\n* Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate.\n* Mavacamten treatment within 8 weeks prior to baseline. Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.",{"count":538,"type":21},36,"The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan",[541],"Cardiomyopathy",[543],"hypertrophic cardiomyopathy (HOCM)",{"date":451,"type":32},{"date":546,"type":32},"2026-02-05",{"date":548,"type":21},"2026-12-31",{"name":38,"class":39},{"id":551,"slug":4,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":557,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":572},"100620736","NCT07361497","A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)","ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.","Inclusion Criteria\n\n* Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.\n* Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).\n* Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n\nExclusion Criteria\n\n* Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.\n* Participants must not have an active autoimmune disease.\n* Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.\n* Participants must not have advanced\u002Fclinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.\n* Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":466,"type":21},[24],"A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)",[560],"Non-small Cell Lung Cancer (NSCLC)",[423,562,563,564,565],"Locally advanced","Unresectable","Stage 3 Non-small Cell Lung Cancer (NSCLC)","CA2660001",{"date":451,"type":32},{"date":568,"type":32},"2026-03-16",{"date":570,"type":21},"2033-12-31",{"name":38,"class":39},255,{"id":574,"slug":4,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":584,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":600},"100620737","NCT07361510","A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)","ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.","Inclusion Criteria\n\n* Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB\u002FIIIC or Stage IV disease.\n* Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.\n* Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n\nExclusion Criteria\n\n* Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.\n* Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.\n* Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.\n* Participants must not an active autoimmune disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":580,"type":21},750,[24],"The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.",[263],[263,585,586,587,588,589,423,590,591,592,593],"1L NSCLC","Programmed death ligand-1 (PD-L1)","Frst line NSCLC","Advanced NSCLC","Metastatic NSCLC","Pembrolizumab","ROSETTA LUNG-202","ROSETTA LUNG","CA2660002",{"date":451,"type":32},{"date":596,"type":32},"2026-03-12",{"date":598,"type":21},"2031-10-14",{"name":38,"class":39},272,{"id":602,"slug":4,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":16,"minAge":109,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":622},"100615495","NCT07293351","A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)","ROSETTA RCC-208: A Phase 1\u002F2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)","Inclusion Criteria\n\n* Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).\n* Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.\n* Participants may have favorable, intermediate or poor risk disease categories.\n* Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:\n\n  i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.\n\nii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab).\n\niii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.\n\n\\- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria\n\n* Participants must not have any untreated known CNS metastases.\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).\n* Participants must not have a history of interstitial lung disease or pneumonitis.\n* Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.\n* Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.\n* Participants must not have a urine protein ≥ 2+ and 24 hour urine protein ≥ 1 g at baseline.\n* Participants must not have evidence of major coagulation disorders.\n* Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.\n* Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.\n* Participants must not have had a major surgery or trauma within 28 days prior to C1D1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":608,"type":21},254,[113,53],"The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)",[612],"Advanced Renal Cell Carcinoma (RCC)",[145,614,423,615,380],"Cabozantinib","Ipilmumab",{"date":451,"type":32},{"date":618,"type":32},"2026-03-26",{"date":620,"type":21},"2031-11-26",{"name":38,"class":39},78,""]