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

Purpose

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.

Conditions

  • High-grade Serous Ovarian Carcinoma (HGSOC)
  • Uterine Serous Carcinoma (USC)
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Dose Escalation
  • Drug: BMS-986463
    Specified dose on specified days
Experimental
Arm 2: Dose Expansion
  • Drug: BMS-986463
    Specified dose on specified days

Recruiting Locations

USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Anastasia Martynova, Site 0003
310-226-2905

Valkyrie Clinical Trials
Los Angeles, California 90067
Contact:
David Berz, Site 0006
424-535-1874

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Martin Gutierrez, Site 0001
551-996-5863

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com