> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-study-of-bms-986500-as-monotherapy-or-combination-d34969aa-e987-4889-910e-0aea7d91d410 > Record changed: 2026-10-13 # A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors NCT06997029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Participants 234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Start date 2025-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) Number of sites 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Title and summary **Summary** The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Short title** A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Official title** A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Dates **Completion date** 2028-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **First posted** 2025-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Registry last updated** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Primary completion date** 2028-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Start date** 2025-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Size and sites **Participants** 234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Planned participants** 234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Number of sites** 21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Identifiers **Registry ID** NCT06997029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **ClinicalTrials.gov ID** NCT06997029 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Outcomes ### Primary outcomes 1. Number of Participants With Dose Limiting Toxicities (DLTs) Timeframe: Up to Day 28 From Last Dose 2. Number of Participants With Adverse Events (AEs) Timeframe: Up to Day 28 From Last Dose 3. Number of Participants With Serious Adverse Events (SAEs) Timeframe: Up to Day 28 From Last Dose 4. Number of Participants With AEs Leading to Discontinuation Timeframe: Up to Day 28 From Last Dose 5. Number of Participants With TEAEs Leading to Death Timeframe: Up to Day 28 From Last Dose ### Secondary outcomes 1. Maximum Observed Serum Concentration (Cmax) of BMS-986500 Timeframe: Up to Approximately 2 Years 2. Time of Maximum Observed Serum Concentration (Tmax) of BMS-986500 Timeframe: Up to Approximately 2 Years 3. Area Under the Concentration-time Curve Within a Dosing Interval (AUC(TAU)) of BMS-986500 Timeframe: Up to Approximately 2 Years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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 ### Exclusion criteria - 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. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Sites - University of Alabama at BirminghamBirmingham, United StatesRecruiting - Providence St. Jude Medical CenterFullerton, United StatesRecruiting - Marin Cancer CareGreenbrae, United StatesRecruiting - Moores Cancer CenterLa Jolla, United StatesRecruiting - Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting - Local Institution - 0008Aurora, United StatesNot yet recruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - Dartmouth-Hitchcock Medical CenterLebanon, United StatesRecruiting - Roswell Park Cancer InstituteBuffalo, United StatesRecruiting - Northwell Health-Cancer InstituteNew Hyde Park, United StatesRecruiting - Local Institution - 0011New York, United StatesNot yet recruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - START Dallas Fort WorthFort Worth, United StatesRecruiting - NEXT OncologySan Antonio, United StatesRecruiting - Odense UniversitetshospitalOdense, DenmarkRecruiting - Copenhagen University HospitalCopenhagen, DenmarkRecruiting - National Cancer Center Hospital EastKashiwa, JapanRecruiting - Kansai Medical University HospitalHirakata, JapanRecruiting - National Cancer Center HospitalChuo-ku, JapanRecruiting - The Cancer Institute Hospital of JFCRKoto-ku, JapanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06997029.html) ### Other registry identifiers (3) - 2025 - U1111-1330-3304 - 2025-524334-26-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06997029) ## Related records ### Drugs (2) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) - [Palbociclib](https://trialight.com/data/asset/palbociclib-2686787c-5f11-4b65-9a5b-549fcd2af644.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) ### Targets (4) - [CCND1](https://trialight.com/data/target/ccnd1-5f6a6270-9aec-5f1d-9fd9-19c16cfaf816.md) - [CDK4](https://trialight.com/data/target/cdk4-7911e947-47b0-5d57-b5c3-76425934201f.md) - [CDK6](https://trialight.com/data/target/cdk6-a48645cb-6daf-5fe9-a635-f8d00b55b425.md) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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