Recruiting
Phase 1
Phase 2

BMS-986482

Sponsor:

Bristol-Myers Squibb

Code:

NCT06697197

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986482

Pumitamig

Study Details

Brief summary:

The purpose of this study is to investigate the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study ID

NCT06697197

Start date

Feb 17, 2025

Status verified date

Sep, 2026

Completion date

Jan 5, 2029

Anticipated

Primary completion date

Jan 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
  • Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.

Exclusion Criteria

  • History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
  • Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
  • For participants in Part 1B1, 1B2, 2B1 and 2B2: active autoimmune disease or requirement for systemic immunosuppressive therapy.
  • For participants in Part 1B1, 1B2, 2B1 and 2B2: History of interstitial lung disease or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
  • For participants in Part 1B1, 1B2, 2B1 and 2B2: 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

286 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A

experimental: Part 1B1

experimental: Part 1B2

experimental: Part 1C

experimental: Part 2B1

experimental: Part 2B2

Interventions

BMS-986482

Specified dose on specified days

Pumitamig

Specified dose on specified days

Primary outcome measure

  • Number of participants with Adverse Events (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) [ Time Frame: Up to 135 days post last treatment visit ]
  • Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0 [ Time Frame: Up to 135 days post last treatment visit ]
  • Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0 [ Time Frame: Up to Day 28 ]
  • Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0 [ Time Frame: Up to 135 days post last treatment visit ]
  • Number of deaths as assessed by NCI-CTCAE v5.0 [ Time Frame: Through study completion (Up to 4 years) ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

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

Recruiting

Irvine, California, United States, 92612

Contacts

Warren Chow, Site 0005

626-372-7121

The Angeles Clinic and Research Institute - West Los Angeles Office

Recruiting

Los Angeles, California, United States, 90025

Contacts

Omid Hamid, Site 0030

310-231-2121

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Martin Gutierrez, Site 0009

551-996-5863

Northwell Health/ RJ Zuckerberg Cancer Center

Recruiting

Lake Success, New York, United States, 11042

Contacts

Nagashree Seetharamu, Site 0007

917-574-8494

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Asim Amin, Site 0011

980-442-2000

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Cristina Rodriguez, Site 0010

206-288-6748

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Oct 21, 2026

Last verified

Sep, 2026

Keywords

  • Immuno-oncology
  • Regulatory T cells
  • Tregs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.