RecruitingPhase 1NCT06476808

A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

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


Sponsor

Bristol-Myers Squibb

Enrollment

240 participants

Start Date

Sep 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

DRUGBMS-986463

Specified dose on specified days


Locations(16)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Local Institution - 0045

Columbus, Ohio, United States

Local Institution - 0046

Dallas, Texas, United States

BC Cancer Vancouver

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Local Institution - 0031

Villejuif, Val-de-Marne, France

Local Institution - 0036

Borddeaux Cedex, France

Local Institution - 0035

Lyon, France

Local Institution - 0032

Rozzano, Milano, Italy

Local Institution - 0033

Milan, Italy

Local Institution - 0041

Avda.Pio XII 36,, Spain

Local Institution - 0042

Barcelona, Spain

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NCT06476808


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