A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

Bristol-Myers Squibb

Summary

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Description

Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue. * Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metas…

Interventions

Drug
BMS-986504
Specified dose on specified days
Drug
Daraxonrasib
Specified dose on specified days
Drug
Nivolumab + Relatlimab FDC
Specified dose on specified days
Drug
Temozolomide
Specified dose on specified days
Drug
Pumitamig
Specified dose on specified days
Drug
Pemetrexed
Specified dose on specified days
Drug
Carboplatin
Specified dose on specified days

Locations (55)

Local Institution - 0096
San Francisco, California
Local Institution - 0182
Aurora, Colorado
Local Institution - 0122
Tampa, Florida
Local Institution - 0178
Atlanta, Georgia
Local Institution - 0106
Chicago, Illinois
Local Institution - 0143
Baltimore, Maryland