Recruiting
Phase 1
Phase 2

BMS-986517

Sponsor:

Bristol-Myers Squibb

Code:

NCT07160725

Conditions

Solid Tumours

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986517

Pumitamig

Study Details

Brief 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

Conditions

Solid Tumours

Study ID

NCT07160725

Start date

Oct 15, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A Monotherapy Dose Escalation

experimental: Part 1B Combination Dose Escalation

experimental: Part 1C: Monotherapy PD Sub-study

experimental: Part 2A: Monotherapy Dose Expansion Cohort A

experimental: Part 2A: Monotherapy Dose Expansion Cohort B

experimental: Part 2A: Monotherapy Dose Expansion Cohort C

experimental: Part 2B: Combination Dose Expansion Cohort A

experimental: Part 2B: Combination Dose Expansion Cohort B

Interventions

BMS-986517

Specified dose on specified days

Pumitamig

Specified dose on specified days

Primary outcome measure

  • Number of Participants with Adverse Events (AE) [ Time Frame: Up to approximately 2 years ]
  • Number of Participants with Serious Adverse Events (SAE) [ Time Frame: Up to approximately 2 years ]
  • Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria [ Time Frame: Up to Day 21 ]
  • Number of Participants with AEs Leading to Discontinuation [ Time Frame: Up to approximately 2 years ]
  • Number of Participants with AEs Leading to Deaths [ Time Frame: Up to approximately 2 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Anthony El-Khoueiry, Site 0002

323-865-3967

University of California, Irvine (UCI) Health - UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3201

Contacts

Rupali Nabar, Site 0021

310-222-2222

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Dan Zandberg, Site 0008

412-864-7955

Sanford Cancer Center

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Steven Powell, Site 0005

605-328-8000

START - Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Henry Xiong, Site 0030

682-350-3010

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Drew Rasco, Site 0020

210-593-5250hopeteam@startresearch.com

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

William McKean, Site 0031

801-907-4750

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Lauren Shih, Site 0028

206-606-7763

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-11.