A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
CA240-0005 (primary)
2025-524285-18 ( Other Identifier ) (OTHER: EU CTR
U1111-1330-1428 ( Other Identifier ) (OTHER: WHO)
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.
Objectives
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
- 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 metastatic disease.
- Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
- Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be = 1.5 × ULN; subjects with liver metastasis or liver cancer must be = 2 × ULN.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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