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NCT Number: NCT07160725

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

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Herlev and Gentofte Hospital, Copenhagen, Capital Region, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986517

Drug

Specified dose on specified days

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545, BNT327, PMS002

Primary outcomes

  1. Number of Participants with Adverse Events (AE)

    Time frame: Up to approximately 2 years

  2. Number of Participants with Serious Adverse Events (SAE)

    Time frame: Up to approximately 2 years

  3. Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria

    Time frame: Up to Day 21

    For part 1 only

  4. Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to approximately 2 years

  5. Number of Participants with AEs Leading to Deaths

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 3 years

  2. Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment

    Time frame: Up to approximately 3 years

  3. Maximum Plasma Concentration (Cmax)

    Time frame: Up to approximately 2 years

  4. Time to Reach Maximum Plasma Concentration (Tmax)

    Time frame: Up to approximately 2 years

  5. Area Under Curve (AUC)

    Time frame: Up to approximately 2 years

  6. Total anti-drug antibodies (ADAs)

    Time frame: Up to approximately 2 Years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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