[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100328442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":360,"collaborators":64,"id":362,"slug":64,"hasResults":363,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":64,"eligibilityCriteria":367,"healthyVolunteers":363,"sex":368,"minAge":369,"maxAge":370,"enrollmentInfo":371,"targetDuration":64,"studyType":374,"phases":375,"briefSummary":378,"conditions":379,"keywords":405,"overallStatus":48,"whyStopped":64,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":435},{"fullName":5,"class":6},"VM Oncology, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VMD-928 monotherapy","EXPERIMENTAL","VMD-928 tablet monotherapy",[13],"Drug: VMD-928 100 mg Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Combination Therapy","VMD-928 tablet in combination with fixed dose of pembrolizumab 200 mg once-very-21-day (per cycle)",[18],"Drug: VMD-928 Tablet and Pembrolizumab (200 mg)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","VMD-928 100 mg Tablet","Taken orally once daily for 21 days per 21-day cycle",[9],[26],"Monotherapy",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"VMD-928 Tablet and Pembrolizumab (200 mg)","VMD-928 tablet (oral) starting at 300 mg daily for 21 days of 21-day cycle. Pemprolizumab at fixed intravenous dose of 200 mg once-every-21 days (per cycle) for max. 6 cycles.",[15],[32],"Combination therapy",[34],{"name":35,"affiliation":36,"role":37},"Clinical Development","VM Oncology","STUDY_CHAIR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Jay Wu, PhD","CONTACT","1-510-270-2790","101","OM@VMOncology.com",[46,73,94,115,136,156,176,196,216,237,256,277,297,317,338],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Providence Medical Foundation (site 209)","RECRUITING","Santa Rosa","California","95403","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.71443,38.44047,{"lat":58,"lon":57},[61,66,70],{"name":62,"role":41,"phone":63,"phoneExt":64,"email":65},"Melissa Ulrich","707-521-3833",null,"melissa.ulrich@providence.org",{"name":67,"role":41,"phone":68,"phoneExt":64,"email":69},"Sam Hansen","707-521-3829","samantha.hansen@stjoe.org",{"name":71,"role":72,"phone":64,"phoneExt":64,"email":64},"Ian C Anderson, MD","PRINCIPAL_INVESTIGATOR",{"facility":74,"status":48,"city":75,"state":76,"zip":77,"country":52,"countryCode":53,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Hartford Hospital (site 210)","Hartford","Connecticut","06102",{"type":55,"coordinates":79},[80,81],-72.68509,41.76371,{"lat":81,"lon":80},[84,88,92],{"name":85,"role":41,"phone":86,"phoneExt":64,"email":87},"Hayley Yackel","860-972-5518","hayley.dunnack@hhchealth.org",{"name":89,"role":41,"phone":90,"phoneExt":64,"email":91},"Christopher Sampson","860-972-5026","christopher.sampson@hhchealth.org",{"name":93,"role":72,"phone":64,"phoneExt":64,"email":64},"Jaykumar Thumar, MD",{"facility":95,"status":48,"city":96,"state":97,"zip":98,"country":52,"countryCode":53,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The George Washington University Cancer Center (site 212)","Washington D.C.","District of Columbia","20037",{"type":55,"coordinates":100},[101,102],-77.03637,38.89511,{"lat":102,"lon":101},[105,109,113],{"name":106,"role":41,"phone":107,"phoneExt":64,"email":108},"Emilie Ginovker, MS, BS","202-994-2524","Emilie.ginovker@gwu.edu",{"name":110,"role":41,"phone":111,"phoneExt":64,"email":112},"Bethel Sebsebie, MS, BS","202-994-1747","Bethel.sebsebie@gwu.edu",{"name":114,"role":72,"phone":64,"phoneExt":64,"email":64},"Sonal Paul, MD",{"facility":116,"status":48,"city":117,"state":118,"zip":119,"country":52,"countryCode":53,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Holy Cross Hospital (site 213)","Fort Lauderdale","Florida","33308",{"type":55,"coordinates":121},[122,123],-80.14338,26.12231,{"lat":123,"lon":122},[126,130,134],{"name":127,"role":41,"phone":128,"phoneExt":64,"email":129},"Eileen Georgi","954-542-7748","eileen.georgi@holy-cross.com",{"name":131,"role":41,"phone":132,"phoneExt":64,"email":133},"Denise Pichardo","954-542-8565","denise.pichardo@holy-cross.com",{"name":135,"role":72,"phone":64,"phoneExt":64,"email":64},"Georges Azzi, MD",{"facility":137,"status":48,"city":138,"state":118,"zip":139,"country":52,"countryCode":53,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Memorial Cancer Institute at Memorial Healthcare Systems (site 132)","Pembroke Pines","33028",{"type":55,"coordinates":141},[142,143],-80.22394,26.00315,{"lat":143,"lon":142},[146,150,154],{"name":147,"role":41,"phone":148,"phoneExt":64,"email":149},"Shoria Martelly","954-844-9917","SMartelly@mhs.net",{"name":151,"role":41,"phone":152,"phoneExt":64,"email":153},"Ines Padron Cubillan","954-844-8737","IPadronCubillan@mhs.net",{"name":155,"role":72,"phone":64,"phoneExt":64,"email":64},"Luis E Raez, MD",{"facility":157,"status":48,"city":158,"state":159,"zip":160,"country":52,"countryCode":53,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Englewood Hospital and Medical Center (site 202)","Englewood","New Jersey","07631",{"type":55,"coordinates":162},[163,164],-73.97264,40.89288,{"lat":164,"lon":163},[167,171,174],{"name":168,"role":41,"phone":169,"phoneExt":64,"email":170},"William Dippolito","201-608-2572","William.Dippolito@EHMCHealth.org",{"name":172,"role":41,"phone":64,"phoneExt":64,"email":173},"Dara Herman","Dara.Herman@EHMCHealth.org",{"name":175,"role":72,"phone":64,"phoneExt":64,"email":64},"Minaxi Jhawer, MD",{"facility":177,"status":48,"city":178,"state":159,"zip":179,"country":52,"countryCode":53,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Summit Medical Group (site 205)","Florham Park","07932",{"type":55,"coordinates":181},[182,183],-74.38821,40.78788,{"lat":183,"lon":182},[186,190,194],{"name":187,"role":41,"phone":188,"phoneExt":64,"email":189},"Michelle Mackenzie","973-436-1755","mmackenzie@summithealth.com",{"name":191,"role":41,"phone":192,"phoneExt":64,"email":193},"Romilda Moreira","973-436-1748","rmoreira2@summithealth.com",{"name":195,"role":72,"phone":64,"phoneExt":64,"email":64},"David Gallinson, DO",{"facility":197,"status":48,"city":198,"state":159,"zip":199,"country":52,"countryCode":53,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Atlantic Health System, Morristown Medical Center (site 124)","Morristown","07962",{"type":55,"coordinates":201},[202,203],-74.48154,40.79677,{"lat":203,"lon":202},[206,210,214],{"name":207,"role":41,"phone":208,"phoneExt":64,"email":209},"Salome Geene","973-971-6373","salome.geene@atlantichealth.org",{"name":211,"role":41,"phone":212,"phoneExt":64,"email":213},"Tracey Hilden, RN, BSN, OCN","973-971-7889","Tracey.Hilden@atlantichealth.org",{"name":215,"role":72,"phone":64,"phoneExt":64,"email":64},"Angela Alistar, MD",{"facility":217,"status":48,"city":218,"state":219,"zip":220,"country":52,"countryCode":53,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Presbyterian Kaseman Hospital (site 208)","Albuquerque","New Mexico","87110",{"type":55,"coordinates":222},[223,224],-106.65114,35.08449,{"lat":224,"lon":223},[227,231,235],{"name":228,"role":41,"phone":229,"phoneExt":64,"email":230},"Matthew Widdows, CCRC","505-559-6089","mwiddows2@phs.org",{"name":232,"role":41,"phone":233,"phoneExt":64,"email":234},"Monique Robertson","505-559-6143","mrobertson2@phs.org",{"name":236,"role":72,"phone":64,"phoneExt":64,"email":64},"Ethan Binder, MD",{"facility":238,"status":48,"city":239,"state":239,"zip":240,"country":52,"countryCode":53,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"Weill Cornell Medicine, Cornell University (site 126)","New York","10065",{"type":55,"coordinates":242},[243,244],-74.00597,40.71427,{"lat":244,"lon":243},[247,251,254],{"name":248,"role":41,"phone":249,"phoneExt":64,"email":250},"Marvin Castellon","646-962-6091","mac7087@med.cornell.edu",{"name":252,"role":41,"phone":64,"phoneExt":64,"email":253},"Jessica Wilk","jsw9043@med.cornell.edu",{"name":255,"role":72,"phone":64,"phoneExt":64,"email":64},"Barbara Ma, M.D., M.S.",{"facility":257,"status":48,"city":258,"state":259,"zip":260,"country":52,"countryCode":53,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Taylor Cancer Research Center (site 204)","Maumee","Ohio","43537",{"type":55,"coordinates":262},[263,264],-83.65382,41.56283,{"lat":264,"lon":263},[267,271,275],{"name":268,"role":41,"phone":269,"phoneExt":64,"email":270},"Stephanie Ambrose, RN, BSN, CCRC","567.402.4502","sambrose@tcrcpt.org",{"name":272,"role":41,"phone":273,"phoneExt":64,"email":274},"Jessica Obarski, RN, CCRC","567.402.4503","jobarski@tcrcpt.org",{"name":276,"role":72,"phone":64,"phoneExt":64,"email":64},"John J Nemunaitis, MD",{"facility":278,"status":48,"city":279,"state":280,"zip":281,"country":52,"countryCode":53,"cosmosGeoPoint":282,"geoPoint":286,"contacts":287},"Cancer Care Associates of York (site 206)","York","Pennsylvania","17403",{"type":55,"coordinates":283},[284,285],-76.72774,39.9626,{"lat":285,"lon":284},[288,292,295],{"name":289,"role":41,"phone":64,"phoneExt":290,"email":291},"Katelyn Bean","1-717-741-9229","kbean@cancercareyork.com",{"name":293,"role":41,"phone":290,"phoneExt":64,"email":294},"Jennifer Stough","jstough@cancercareyork.com",{"name":296,"role":72,"phone":64,"phoneExt":64,"email":64},"Chanh Huynh, MD",{"facility":298,"status":48,"city":299,"state":300,"zip":301,"country":52,"countryCode":53,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"The University of Texas MD Anderson Cancer Center (site 127)","Houston","Texas","77030",{"type":55,"coordinates":303},[304,305],-95.36327,29.76328,{"lat":305,"lon":304},[308,311,315],{"name":309,"role":41,"phone":64,"phoneExt":64,"email":310},"Madison Maas","MEMaas@mdanderson.org",{"name":312,"role":41,"phone":313,"phoneExt":64,"email":314},"Ly M Nguyen","713-563-2169","LMNguyen1@mdanderson.org",{"name":316,"role":72,"phone":64,"phoneExt":64,"email":64},"David S Hong, MD",{"facility":318,"status":48,"city":319,"state":320,"zip":321,"country":52,"countryCode":53,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Utah Cancer Specialists (site 203)","Salt Lake City","Utah","84106",{"type":55,"coordinates":323},[324,325],-111.89105,40.76078,{"lat":325,"lon":324},[328,332,336],{"name":329,"role":41,"phone":330,"phoneExt":64,"email":331},"Angela Nuttall","801-269-0231","anuttall@utahcancer.com",{"name":333,"role":41,"phone":334,"phoneExt":64,"email":335},"Angie Sonntag","801-267-5605","asonntag@utahcancer.com; studies@utahcancer.com",{"name":337,"role":72,"phone":64,"phoneExt":64,"email":64},"Stephan DiSean Kendall, MD",{"facility":339,"status":48,"city":340,"state":64,"zip":341,"country":342,"countryCode":343,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"PanOncology Trials, Hospital Oncologico - Puerto Rico Medical Center, Río Piedras (site 200)","San Juan","00935","Puerto Rico","PR",{"type":55,"coordinates":345},[346,347],-66.10572,18.46633,{"lat":347,"lon":346},[350,354,358],{"name":351,"role":41,"phone":352,"phoneExt":64,"email":353},"Astrid K Martínez","(787) 407-3333","astrid.martinez@panoncologytrials.com",{"name":355,"role":41,"phone":356,"phoneExt":64,"email":357},"Carlos Quijano","(787) 607-3338","carlos.quijano@panoncologytrials.com",{"name":359,"role":72,"phone":64,"phoneExt":64,"email":64},"Marcia Cruz-Correa, MD, PhD, AGAF, FASGE",{"type":361,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100328442",false,"NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.","ALL","18 Years","80 Years",{"count":372,"type":373},242,"ESTIMATED","INTERVENTIONAL",[376,377],"PHASE1","PHASE2","This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404],"Head and Neck Carcinoma","Adenoid Cystic Carcinoma","Lung Cancer","Non-Small Cell Lung Cancer","Pancreatic Cancer","Mesothelioma","Esophageal Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Head and Neck Cancers - Throat","Small Cell Lung Cancer ( SCLC )","Lung Cancer (Locally Advanced or Metastatic)","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[406,407,380,381,382,383,408,385,409,410,411,412,413,414,415,402,416,417,418,419,420,421,422,423,424,425],"TrkA","NTRK1","NSCLC","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","SCLC","ACC","HNSCC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea","2025-12-04",{"date":428,"type":429},"2025-12-11","ACTUAL",{"date":431,"type":429},"2018-06-08",{"date":433,"type":373},"2028-06",{"name":5,"class":6},15]