A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors (NCT07160725) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors
United States, China, Denmark540 participantsStarted 2025-10-15
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
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
Trial details
NCT IDNCT07160725
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-07-31
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com