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RecruitingInterventionalPhase 1

A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors

NCT ID: NCT06476808Sponsor: Bristol-Myers SquibbLast updated: 2026-04-15

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Arms & interventions

  • DrugBMS-986463

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with adverse events (AEs)

    Time frame: Up to 108 weeks

  • Number of participants with serious adverse events (SAEs)

    Time frame: Up to 108 weeks

  • Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to 108 weeks

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to 108 weeks

  • Number of participants with AEs leading to death

    Time frame: Up to 108 weeks

Secondary

  • Maximum observed concentration (Cmax)

    Time frame: Up to 104 weeks

  • Area under the concentration-time curve (AUC)

    Time frame: Up to 104 weeks

  • Time of maximum observed concentration (Tmax)

    Time frame: Up to 104 weeks

  • Objective response rate (ORR)

    Time frame: Up to 104 weeks

  • Disease control rate (DCR)

    Time frame: Up to 104 weeks

  • Duration of response (DOR)

    Time frame: Up to 104 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained. * Participants must have an unresectable/metastatic carcinoma. Exclusion Criteria * Participants must not have Leptomeningeal metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations (6)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting
Anastasia Martynova, Site 0003 · Contact
310-226-2905

Valkyrie Clinical Trials

Los Angeles, California, 90067

Recruiting
David Berz, Site 0006 · Contact
424-535-1874

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Martin Gutierrez, Site 0001 · Contact
551-996-5863

Local Institution - 0045

Columbus, Ohio, 43210

Not Yet Recruiting
Site 0045 · Contact

Local Institution - 0046

Dallas, Texas, 75390

Not Yet Recruiting
Site 0046 · Contact

Local Institution - 0049

Houston, Texas, 77054

Not Yet Recruiting
Site 0049 · Contact