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NCT07492680

PHASE2

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)

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-07-17

Completion Date

2032-05-20

Last Updated

2026-03-25

Healthy Volunteers

No

Conditions

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

DRUG

Nab-paclitaxel

Specified dose on specified days

DRUG

Gemcitabine

Specified dose on specified days

DRUG

Paclitaxel

Specified dose on specified days

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 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) should be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer should be ≤ 2 × ULN. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor. * Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Participants must not have history of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. * Participants must not have inadequate organ function, as determined by laboratory testing within the screening period. * Participants must not have active viral HBV or HCV hepatitis. Other protocol defined inclusion/exclusion criteria applies.

Locations (55)

Local Institution - 0096

San Francisco, California, United States

Local Institution - 0182

Aurora, Colorado, United States

Local Institution - 0122

Tampa, Florida, United States

Local Institution - 0178

Atlanta, Georgia, United States

Local Institution - 0106

Chicago, Illinois, United States

Local Institution - 0143

Baltimore, Maryland, United States

Local Institution - 0124

Boston, Massachusetts, United States

Local Institution - 0119

Ann Arbor, Michigan, United States

Local Institution - 0129

Rochester, Minnesota, United States

Local Institution - 0174

Rochester, Minnesota, United States

Local Institution - 0181

Rochester, Minnesota, United States

Local Institution - 0142

Buffalo, New York, United States

Local Institution - 0170

New York, New York, United States

Local Institution - 0139

New York, New York, United States

Local Institution - 0100

Durham, North Carolina, United States

Local Institution - 0085

Houston, Texas, United States

Local Institution - 0086

Seattle, Washington, United States

Local Institution - 0134

Madison, Wisconsin, United States

Local Institution - 0114

Ghent, Oost-Vlaanderen, Belgium

Local Institution - 0051

Abbotsford British Columbia, British Columbia, Canada

Local Institution - 0021

Toronto, Ontario, Canada

Local Institution - 0007

Toronto, Ontario, Canada

Local Institution - 0155

Beijing, Beijing Municipality, China

Local Institution - 0153

Shanghai, Shanghai Municipality, China

Local Institution - 0156

Shanghai, Shanghai Municipality, China

Local Institution - 0078

Dijon, Côte-d'Or, France

Local Institution - 0075

Pierre-Bénite, Rhône, France

Local Institution - 0116

Villejuif, Val-de-Marne, France

Local Institution - 0074

Paris, France

Local Institution - 0081

Mainz, Rhineland-Palatinate, Germany

Local Institution - 0040

Hamburg, Germany

Local Institution - 0039

Heidelberg, Germany

Local Institution - 0061

Leipzig, Germany

Local Institution - 0049

München, Germany

Local Institution - 0047

Würzburg, Germany

Local Institution - 0063

Shatin, Hong Kong

Local Institution - 0080

Cork, Ireland

Local Institution - 0023

Dublin, Ireland

Local Institution - 0146

Dublin, Ireland

Local Institution - 0073

Siena, Tuscany, Italy

Local Institution - 0123

Bergamo, Italy

Local Institution - 0034

Milan, Italy

Local Institution - 0050

Naples, Italy

Local Institution - 0082

Perugia, Italy

Local Institution - 0020

Chuo-ku, Tokyo, Japan

Local Institution - 0171

Bergen, Hordaland, Norway

Local Institution - 0022

Oslo, Norway

Local Institution - 0004

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0058

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0052

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 0068

Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0071

Hospitalet, Barcelona [Barcelona], Spain

Local Institution - 0033

Madrid, Spain

Local Institution - 0059

Madrid, Spain

Local Institution - 0069

Seville, Spain