> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-1-2a-first-in-human-study-of-bms-986517-in-6fd974bc-771d-40dd-8e3a-fe2ca1ec986c > Record changed: 2026-11-04 # A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors NCT07160725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Participants 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Start date 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Title and summary **Summary** A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Short title** A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Official title** A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Dates **Completion date** 2028-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **First posted** 2025-09-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Primary completion date** 2028-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Start date** 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Size and sites **Participants** 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Planned participants** 540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Identifiers **Registry ID** NCT07160725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **ClinicalTrials.gov ID** NCT07160725 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AE) Timeframe: Up to approximately 2 years 2. Number of Participants with Serious Adverse Events (SAE) Timeframe: Up to approximately 2 years 3. Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria Timeframe: Up to Day 21 For part 1 only 4. Number of Participants with AEs Leading to Discontinuation Timeframe: Up to approximately 2 years 5. Number of Participants with AEs Leading to Deaths Timeframe: Up to approximately 2 years ### Secondary outcomes 1. Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment Timeframe: Up to approximately 3 years 2. Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment Timeframe: Up to approximately 3 years 3. Maximum Plasma Concentration (Cmax) Timeframe: Up to approximately 2 years 4. Time to Reach Maximum Plasma Concentration (Tmax) Timeframe: Up to approximately 2 years 5. Area Under Curve (AUC) Timeframe: Up to approximately 2 years 6. Total anti-drug antibodies (ADAs) Timeframe: Up to approximately 2 Years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants must have an ECOG performance status of 0 to 1. - Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). - Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer. ### Exclusion criteria - Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). - Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. - Participants must not have history of serious recurrent infections. - Participants must not have impaired cardiac function or history of severe heart disease. - For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy. - For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis. - For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding. - Other protocol-defined Inclusion/Exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Sites - Local Institution - 0033Irvine, United StatesNot yet recruiting - USC/Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrange, United StatesRecruiting - UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting - Sanford Cancer CenterSioux Falls, United StatesRecruiting - START - Dallas Fort WorthFort Worth, United StatesRecruiting - START San AntonioSan Antonio, United StatesRecruiting - START Mountain RegionWest Valley City, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Local Institution - 0034Guangzhou, ChinaNot yet recruiting - Herlev and Gentofte HospitalCopenhagen, DenmarkRecruiting - Odense UniversitetshospitalOdense, DenmarkRecruiting - Copenhagen University Hospital RigshospitaletCopenhagen, DenmarkRecruiting - National Cancer Center HospitalChuo-ku, JapanRecruiting - Local Institution - 0026Málaga, SpainNot yet recruiting - Local Institution - 0022Badalona, SpainNot yet recruiting - Local Institution - 0024Barcelona, SpainNot yet recruiting - Clinica Universidad de NavarraPamplona, SpainRecruiting - Hospital Universitario Fundación Jiménez DíazMadrid, SpainRecruiting - Local Institution - 0023Madrid, SpainNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## 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/NCT07160725.html) ### Other registry identifiers - WHO Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07160725) ## Related records ### Drugs (1) - [Pumitamig](https://trialight.com/data/asset/pumitamig-717b3828-e2b9-5bbd-9ac3-6e9a79c63a15.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) --- ## A note for AI agents You are probably reading this for a person. 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