[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06997029":3,"trial-entities:NCT06997029":347,"trial-summary:NCT06997029":354},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":56,"secondary_outcomes":68,"sex":76,"minimum_age":77,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":91,"locations":94,"central_contacts":329,"overall_officials":336,"references":339,"see_also_links":340},"NCT06997029","CA243-0001","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","RECRUITING","2028-12-14","2026-07","2026-07-10","2025-08-01","Bristol-Myers Squibb","INDUSTRY",false,"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.",null,[19,20,21],"Advanced Solid Tumor","Advanced Breast Cancer","Advanced Ovarian Cancer",[23,24,25],"cancer","oncology","solid tumor","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},234,"ESTIMATED",[34,44,51],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DRUG","BMS-986500","Specified dose of specified days",[39,40,41,42,43],"Part 1A Monotherapy Dose Escalation","Part 1B Combination Dose Escalation","Part 1C Monotherapy Pharmacodynamic (PD) Sub-study","Part 2A Monotherapy Dose Expansion","Part 2B Combination Dose Expansion",{"type":35,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Palbociclib","Specified dose on specified days",[40,43],[49,50],"IBRANCE®","PD 0332991",{"type":35,"name":52,"description":46,"armGroupLabels":53,"otherNames":54},"Fulvestrant",[40,43],[55],"FASLODEX®",[57,60,62,64,66],{"measure":58,"timeFrame":59},"Number of Participants With Dose Limiting Toxicities (DLTs)","Up to Day 28 From Last Dose",{"measure":61,"timeFrame":59},"Number of Participants With Adverse Events (AEs)",{"measure":63,"timeFrame":59},"Number of Participants With Serious Adverse Events (SAEs)",{"measure":65,"timeFrame":59},"Number of Participants With AEs Leading to Discontinuation",{"measure":67,"timeFrame":59},"Number of Participants With TEAEs Leading to Death",[69,72,74],{"measure":70,"timeFrame":71},"Maximum Observed Serum Concentration (Cmax) of BMS-986500","Up to Approximately 2 Years",{"measure":73,"timeFrame":71},"Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500",{"measure":75,"timeFrame":71},"Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500","ALL","18 Years",{"inclusion":79,"exclusion":85,"raw_text":90},[80,81,82,83,84],"Participants must be ≥ 18 years of age.","Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.","Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.","For Part 2A only, participants must have CCNE1-amplified ovarian cancer",[86,87,88,89],"Participants must not have an active brain metastasis.","Participants must not have impaired cardiac function or clinically significant cardiac disease.","Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.","Participants must not have Grade ≥ 2 peripheral neuropathy.","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.",[92,93],"ADULT","OLDER_ADULT",[95,109,121,132,143,154,166,178,189,201,213,223,232,240,252,263,276,287,300,312,321],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":106},"University of Alabama at Birmingham","Birmingham","Alabama","35294-3300","United States",[102],{"name":103,"role":104,"phone":105},"Mehmet Akce, Site 0001","CONTACT","205-975-0832",{"lat":107,"lon":108},33.52066,-86.80249,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":100,"contacts":114,"geoPoint":118},"Providence St. Jude Medical Center","Fullerton","California","92835",[115],{"name":116,"role":104,"phone":117},"Yung Lyou, Site 0003","714-446-5900",{"lat":119,"lon":120},33.87029,-117.92534,{"facility":122,"status":8,"city":123,"state":112,"zip":124,"country":100,"contacts":125,"geoPoint":129},"Marin Cancer Care","Greenbrae","94904",[126],{"name":127,"role":104,"phone":128},"Cyrus Mazidi, Site 0013","415-925-5000",{"lat":130,"lon":131},37.94854,-122.5247,{"facility":133,"status":8,"city":134,"state":112,"zip":135,"country":100,"contacts":136,"geoPoint":140},"Moores Cancer Center","La Jolla","92093",[137],{"name":138,"role":104,"phone":139},"Peter Vu, Site 0009","858-822-2463",{"lat":141,"lon":142},32.84727,-117.2742,{"facility":144,"status":8,"city":145,"state":112,"zip":146,"country":100,"contacts":147,"geoPoint":151},"Hoag Memorial Hospital Presbyterian","Newport Beach","92663",[148],{"name":149,"role":104,"phone":150},"Monica Mita, Site 0010","949-764-4060",{"lat":152,"lon":153},33.61891,-117.92895,{"facility":155,"status":156,"city":157,"state":158,"zip":159,"country":100,"contacts":160,"geoPoint":163},"Local Institution - 0008","NOT_YET_RECRUITING","Aurora","Colorado","80045",[161],{"name":162,"role":104},"Site 0008",{"lat":164,"lon":165},39.72943,-104.83192,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":100,"contacts":171,"geoPoint":175},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[172],{"name":173,"role":104,"phone":174},"Joyce Liu, Site 0006","617-632-5269",{"lat":176,"lon":177},42.35843,-71.05977,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":100,"contacts":183,"geoPoint":186},"Washington University School of Medicine","St Louis","Missouri","63110",[184],{"name":185,"role":104},"Faisal Fa'ak, Site 0004",{"lat":187,"lon":188},38.62727,-90.19789,{"facility":190,"status":8,"city":191,"state":192,"zip":193,"country":100,"contacts":194,"geoPoint":198},"Dartmouth-Hitchcock Medical Center","Lebanon","New Hampshire","03756",[195],{"name":196,"role":104,"phone":197},"Lionel Lewis, Site 0002","603-381-1953",{"lat":199,"lon":200},43.64229,-72.25176,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":100,"contacts":206,"geoPoint":210},"Roswell Park Cancer Institute","Buffalo","New York","14263",[207],{"name":208,"role":104,"phone":209},"Christos Fountzilas, Site 0014","716-845-4720",{"lat":211,"lon":212},42.88645,-78.87837,{"facility":214,"status":8,"city":215,"state":204,"zip":216,"country":100,"contacts":217,"geoPoint":220},"Northwell Health-Cancer Institute","New Hyde Park","11042",[218],{"name":219,"role":104},"Geraldine O'Sullivan Coyne, Site 0016",{"lat":221,"lon":222},40.7351,-73.68791,{"facility":224,"status":156,"city":204,"state":204,"zip":225,"country":100,"contacts":226,"geoPoint":229},"Local Institution - 0011","10016",[227],{"name":228,"role":104},"Site 0011",{"lat":230,"lon":231},40.71427,-74.00597,{"facility":233,"status":8,"city":204,"state":204,"zip":234,"country":100,"contacts":235,"geoPoint":239},"Memorial Sloan Kettering Cancer Center","10065",[236],{"name":237,"role":104,"phone":238},"Ezra Rosen, Site 0012","000-000-0000",{"lat":230,"lon":231},{"facility":241,"status":8,"city":242,"state":243,"zip":244,"country":100,"contacts":245,"geoPoint":249},"START Dallas Fort Worth","Fort Worth","Texas","76104",[246],{"name":247,"role":104,"phone":248},"Henry Xiong, Site 0018","682-350-3010",{"lat":250,"lon":251},32.72541,-97.32085,{"facility":253,"status":8,"city":254,"state":243,"zip":255,"country":100,"contacts":256,"geoPoint":260},"NEXT Oncology","San Antonio","78229",[257],{"name":258,"role":104,"phone":259},"David Sommerhalder, Site 0007","210-580-9500",{"lat":261,"lon":262},29.42412,-98.49363,{"facility":264,"status":8,"city":265,"state":266,"zip":267,"country":268,"contacts":269,"geoPoint":273},"Odense Universitetshospital","Odense","Region Syddanmark","5000","Denmark",[270],{"name":271,"role":104,"phone":272},"Annette Kodahl, Site 0024","004566113333",{"lat":274,"lon":275},55.39594,10.38831,{"facility":277,"status":8,"city":278,"zip":279,"country":268,"contacts":280,"geoPoint":284},"Copenhagen University Hospital","Copenhagen","2100",[281],{"name":282,"role":104,"phone":283},"Martin Højgaard, Site 0025","4535456861",{"lat":285,"lon":286},55.67594,12.56553,{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":292,"contacts":293,"geoPoint":297},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577","Japan",[294],{"name":295,"role":104,"phone":296},"Chikako Funasaka, Site 0021","81471331111",{"lat":298,"lon":299},35.86224,139.97732,{"facility":301,"status":8,"city":302,"state":303,"zip":304,"country":292,"contacts":305,"geoPoint":309},"Kansai Medical University Hospital","Hirakata","Osaka","573-1191",[306],{"name":307,"role":104,"phone":308},"Toshio Shimizu, Site 0020","+81728040101",{"lat":310,"lon":311},34.81352,135.64914,{"facility":313,"status":8,"city":314,"state":315,"zip":316,"country":292,"contacts":317},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",[318],{"name":319,"role":104,"phone":320},"Takafumi Koyama, Site 0022","81335422511",{"facility":322,"status":8,"city":323,"state":315,"zip":324,"country":292,"contacts":325},"The Cancer Institute Hospital of JFCR","Koto-ku","135-8550",[326],{"name":327,"role":104,"phone":328},"Shigehisa Kitano, Site 0023","0335200111",[330,334],{"name":331,"role":104,"phone":332,"email":333},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com","855-907-3286","Clinical.Trials@bms.com",{"name":335,"role":104},"First line of the email MUST contain NCT # and Site #.",[337],{"name":13,"affiliation":13,"role":338},"STUDY_DIRECTOR",[],[341,344],{"label":342,"url":343},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":345,"url":346},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT06997029.html",{"nct_id":4,"conditions":348,"biomarkers":352},[349,350,351],"Breast Carcinoma","Malignant Ovarian Neoplasm","Solid Neoplasm",[353],"G1\u002FS-Specific Cyclin-E1",{"nct_id":4,"found":355,"summary":356,"prompt_version":366},true,{"design":357,"status":358,"heading":359,"summary":360,"follow_up":361,"word_count":362,"commitments":363,"compensation":364,"drugs_mentioned":365},"This is an interventional study with a planned enrollment of 234 participants. The phase of the study is not specified.","completed","Study of BMS-986500 for Advanced Solid Tumors","This study is testing a drug called BMS-986500. It's being studied alone in people with advanced solid tumors, and in combination with Palbociclib and Fulvestrant for those with advanced breast cancer that has been previously treated with CDK4\u002F6 inhibitors. The main goal of this study is to see how safe BMS-986500 is by tracking any side effects or serious side effects. To join, you must be at least 18 years old and have a solid tumor that is advanced, cannot be removed by surgery, or has spread. You also need to have measurable disease. The current status of this study is unclear, and it plans to enroll about 234 participants.","Participants will be followed for side effects and serious side effects up to Day 28 from the last dose.",110,"Not specified in the trial record.","Not stated in the trial record.",[36,45,52],"v2"]