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Phase 1/2a Study of BMS-986517 for Advanced Solid Tumors

This study is testing a new drug called BMS-986517 in people with advanced solid tumors. It's a "first-in-human" study, meaning it's one of the first times this drug is being given to people. Researchers want to see how safe BMS-986517 is and what side effects it might cause. Some participants may also receive Pumitamig. You might be able to join if you are 18 or older, have advanced solid tumors that can be measured, and have a good general health status (ECOG performance status of 0 to 1). The main goals are to track any side effects, including serious ones, for up to about two years.

Study design
This is a Phase 1/2a, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 540 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) for up to approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07160725

A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~540 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:BMS-986517Pumitamig

At a glance

Recruiting sites
14 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AE)
Measured over Up to approximately 2 years
+4 more outcomes measured

Conditions

Solid Tumours

Explore related trials

Breast CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

20 sites across 15 states
California3
Texas2
Barcelona [Barcelona]2
Spain2
Pennsylvania1
South Dakota1
Utah1
Washington1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Adverse Events (AE)Up to approximately 2 years
  • Number of Participants with Serious Adverse Events (SAE)Up to approximately 2 years
  • Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteriaUp to Day 21

    For part 1 only

  • Number of Participants with AEs Leading to DiscontinuationUp to approximately 2 years
  • Number of Participants with AEs Leading to DeathsUp to approximately 2 years