[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06476808":3,"trial-entities:NCT06476808":278,"trial-summary:NCT06476808":285},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":50,"sex":64,"minimum_age":65,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":76,"locations":79,"central_contacts":260,"overall_officials":267,"references":270,"see_also_links":271},"NCT06476808","CA231-0000","A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.","A Phase 1\u002F1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors","RECRUITING","2028-12-19","2026-07","2026-07-20","2024-09-06","Bristol-Myers Squibb","INDUSTRY",false,"The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.",null,[19,20,21],"High-grade Serous Ovarian Carcinoma (HGSOC)","Uterine Serous Carcinoma (USC)","Non-small Cell Lung Cancer (NSCLC)",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},240,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","BMS-986463","Specified dose on specified days",[36,37],"Arm 1: Dose Escalation","Arm 2: Dose Expansion",[39,42,44,46,48],{"measure":40,"timeFrame":41},"Number of participants with adverse events (AEs)","Up to 108 weeks",{"measure":43,"timeFrame":41},"Number of participants with serious adverse events (SAEs)",{"measure":45,"timeFrame":41},"Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria",{"measure":47,"timeFrame":41},"Number of participants with AEs leading to discontinuation",{"measure":49,"timeFrame":41},"Number of participants with AEs leading to death",[51,54,56,58,60,62],{"measure":52,"timeFrame":53},"Maximum observed concentration (Cmax)","Up to 104 weeks",{"measure":55,"timeFrame":53},"Area under the concentration-time curve (AUC)",{"measure":57,"timeFrame":53},"Time of maximum observed concentration (Tmax)",{"measure":59,"timeFrame":53},"Objective response rate (ORR)",{"measure":61,"timeFrame":53},"Disease control rate (DCR)",{"measure":63,"timeFrame":53},"Duration of response (DOR)","ALL","18 Years",{"inclusion":67,"exclusion":71,"raw_text":75},[68,69,70],"Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.","Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.","Participants must have an unresectable\u002Fmetastatic carcinoma.",[72,73,74],"Participants must not have Leptomeningeal metastases.","Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.","Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.","Inclusion Criteria\n\n* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.\n* Participants must have an unresectable\u002Fmetastatic carcinoma.\n\nExclusion Criteria\n\n* Participants must not have Leptomeningeal metastases.\n* Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.\n* Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",[77,78],"ADULT","OLDER_ADULT",[80,94,102,114,126,135,145,158,170,182,190,202,213,223,234,241,253],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":91},"USC\u002FNorris Comprehensive Cancer Center","Los Angeles","California","90033","United States",[87],{"name":88,"role":89,"phone":90},"Anastasia Martynova, Site 0003","CONTACT","310-226-2905",{"lat":92,"lon":93},34.05223,-118.24368,{"facility":95,"status":8,"city":82,"state":83,"zip":96,"country":85,"contacts":97,"geoPoint":101},"Valkyrie Clinical Trials","90067",[98],{"name":99,"role":89,"phone":100},"David Berz, Site 0006","424-535-1874",{"lat":92,"lon":93},{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":85,"contacts":107,"geoPoint":111},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601",[108],{"name":109,"role":89,"phone":110},"Martin Gutierrez, Site 0001","551-996-5863",{"lat":112,"lon":113},40.88593,-74.04347,{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":85,"contacts":120,"geoPoint":123},"Local Institution - 0045","NOT_YET_RECRUITING","Columbus","Ohio","43210",[121],{"name":122,"role":89},"Site 0045",{"lat":124,"lon":125},39.96118,-82.99879,{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":85,"geoPoint":132},"Local Institution - 0046","WITHDRAWN","Dallas","Texas","75390",{"lat":133,"lon":134},32.78306,-96.80667,{"facility":136,"status":116,"city":137,"state":130,"zip":138,"country":85,"contacts":139,"geoPoint":142},"Local Institution - 0049","Houston","77054",[140],{"name":141,"role":89},"Site 0049",{"lat":143,"lon":144},29.76328,-95.36327,{"facility":146,"status":8,"city":147,"state":148,"zip":149,"country":150,"contacts":151,"geoPoint":155},"BC Cancer Vancouver","Vancouver","British Columbia","V5Z 4E6","Canada",[152],{"name":153,"role":89,"phone":154},"Yvette Drew, Site 0026","604-877-6000",{"lat":156,"lon":157},49.24966,-123.11934,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":150,"contacts":163,"geoPoint":167},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 2M9",[164],{"name":165,"role":89,"phone":166},"Amit Oza, Site 0027","416-946-2818",{"lat":168,"lon":169},43.70643,-79.39864,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":150,"contacts":175,"geoPoint":179},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2X 3E4",[176],{"name":177,"role":89,"phone":178},"Diane Provencher, Site 0028","514 890-8000",{"lat":180,"lon":181},45.50884,-73.58781,{"facility":183,"status":8,"city":172,"state":173,"zip":184,"country":150,"contacts":185,"geoPoint":189},"Jewish General Hospital","H3T 1E2",[186],{"name":187,"role":89,"phone":188},"Susie Lau, Site 0024","5143408222ext23114",{"lat":180,"lon":181},{"facility":191,"status":116,"city":192,"state":193,"zip":194,"country":195,"contacts":196,"geoPoint":199},"Local Institution - 0036","Bordeaux","Aquitaine","33076","France",[197],{"name":198,"role":89},"Site 0036",{"lat":200,"lon":201},44.84124,-0.58046,{"facility":203,"status":116,"city":204,"state":205,"zip":206,"country":195,"contacts":207,"geoPoint":210},"Local Institution - 0031","Villejuif","Val-de-Marne","94800",[208],{"name":209,"role":89},"Site 0031",{"lat":211,"lon":212},48.7939,2.35992,{"facility":214,"status":116,"city":215,"zip":216,"country":195,"contacts":217,"geoPoint":220},"Local Institution - 0035","Lyon","69373",[218],{"name":219,"role":89},"Site 0035",{"lat":221,"lon":222},45.74906,4.84789,{"facility":224,"status":116,"city":225,"zip":226,"country":227,"contacts":228,"geoPoint":231},"Local Institution - 0033","Milan","20141","Italy",[229],{"name":230,"role":89},"Site 0033",{"lat":232,"lon":233},42.78235,12.59836,{"facility":235,"status":116,"city":225,"zip":236,"country":227,"contacts":237,"geoPoint":240},"Local Institution - 0032","20159",[238],{"name":239,"role":89},"Site 0032",{"lat":232,"lon":233},{"facility":242,"status":116,"city":243,"state":244,"zip":245,"country":246,"contacts":247,"geoPoint":250},"Local Institution - 0042","Barcelona","Barcelona [Barcelona]","08035","Spain",[248],{"name":249,"role":89},"Site 0042",{"lat":251,"lon":252},41.38879,2.15899,{"facility":254,"status":116,"city":255,"zip":256,"country":246,"contacts":257},"Local Institution - 0041","Avda.Pio XII 36,","31008",[258],{"name":259,"role":89},"Site 0041",[261,265],{"name":262,"role":89,"phone":263,"email":264},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":266,"role":89},"First line of the email MUST contain NCT # and Site #.",[268],{"name":13,"affiliation":13,"role":269},"STUDY_DIRECTOR",[],[272,275],{"label":273,"url":274},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":276,"url":277},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT06476808.html",{"nct_id":4,"conditions":279,"biomarkers":284},[280,281,282,283],"Endometrial Serous Adenocarcinoma","Lung Non-Small Cell Carcinoma","Ovarian High Grade Serous Adenocarcinoma","Solid Neoplasm",[],{"nct_id":4,"found":286,"summary":287,"prompt_version":297},true,{"design":288,"status":289,"heading":290,"summary":291,"follow_up":292,"word_count":293,"commitments":294,"compensation":295,"drugs_mentioned":296},"This is an interventional study, meaning participants will receive a specific treatment. The planned enrollment is 240 participants.","completed","A Study of BMS-986463 for Advanced Malignant Tumors","This study is testing a new drug called BMS-986463 in people with certain advanced cancers, including high-grade serous ovarian carcinoma (HGSOC), uterine serous carcinoma (USC), and non-small cell lung cancer (NSCLC). The main goal is to see how safe BMS-986463 is and how well your body tolerates different doses. Researchers will also look at how effective the drug is. To join, you must be at least 18 years old, have a good general health status (ECOG 0 or 1), and have cancer that cannot be removed by surgery or has spread. You'll also need to have a tumor that can be biopsied. The study is currently recruiting participants.","Your safety will be monitored for up to 108 weeks (about 2 years) to track any side effects.",108,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]