A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

Description

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

Conditions

Advanced Solid Tumors

Study Overview

Study Details

Study overview

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

A Phase 1/2 Study of BMS-986482 as Monotherapy or Combination Therapy in Participants With Advanced Solid Tumors

A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Irvine

Local Institution - 0005, Irvine, California, United States, 92612

Los Angeles

Local Institution - 0030, Los Angeles, California, United States, 90025

Aurora

Local Institution - 0008, Aurora, Colorado, United States, 80045

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Lake Success

Local Institution - 0007, Lake Success, New York, United States, 11042

Charlotte

Local Institution - 0011, Charlotte, North Carolina, United States, 28204

Seattle

Local Institution - 0010, Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).
  • * Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should have documented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skipping mutations, and BRAF V600E.Participants must have received platinum-based chemotherapy and anti-PD-(L)1 therapy, if eligible and available.
  • * Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, or unknown primary melanoma. Participants with uveal/ocular melanoma are excluded. Participants must be melanoma 2L+.
  • * Participants in Part 1B3 must have advanced or metastatic MSS-CRC.
  • * Participants in Part 2A may have advanced solid tumors (advanced, unresectable, or metastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer or pancreatic adenocarcinoma \[PDAC\]) based on emerging data.
  • * Participants in Part 2B3 must have advanced or metastatic MSS-CRC.
  • * For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy \[core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen\] must be obtained (obtained within 1 month of the start of the Screening, if there are tumor sites that can be biopsied with acceptable clinical risk).
  • * 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.
  • * Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2029-01-05