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NCT07492680PHASE2Recruiting

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)

Bristol-Myers Squibb

Start Date

7/27/2026

Completion Date

5/20/2032

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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) 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. 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 within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) 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.

Interventions

DRUG

BMS-986504

DRUG

Daraxonrasib

DRUG

Nivolumab + Relatlimab FDC

DRUG

Temozolomide

DRUG

Pumitamig

DRUG

Pemetrexed

DRUG

Carboplatin

DRUG

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

Paclitaxel

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Conditions

Solid Tumors

Locations

Local Institution - 0096

San Francisco, California 94158

United States

Local Institution - 0182

Aurora, Colorado 80045

United States

Local Institution - 0178

Atlanta, Georgia 30322

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Local Institution - 0124

Boston, Massachusetts 02114

United States

Local Institution - 0119

Ann Arbor, Michigan 48109-0922

United States

Local Institution - 0129

Rochester, Minnesota 55905

United States

Local Institution - 0174

Rochester, Minnesota 55905

United States

Local Institution - 0181

Rochester, Minnesota 55905

United States

Local Institution - 0142

Buffalo, New York 14263

United States

Local Institution - 0170

New York, New York 10016

United States

Local Institution - 0139

New York, New York 10065

United States

Local Institution - 0100

Durham, North Carolina 27705

United States

Local Institution - 0085

Houston, Texas 77030

United States

Local Institution - 0086

Seattle, Washington 98109

United States

Local Institution - 0134

Madison, Wisconsin 53792

United States

Local Institution - 0148

Brussels, Bruxelles-Capitale, Région de 1200

Belgium

Local Institution - 0114

Ghent, Oost-Vlaanderen 9000

Belgium

Local Institution - 0051

Vancouver, British Columbia V2S 0C2

Canada

Local Institution - 0021

Toronto, Ontario M4N 3M5

Canada

Local Institution - 0007

Toronto, Ontario M5G 2M9

Canada

Local Institution - 0155

Beijing, Beijing Municipality 100071

China

Local Institution - 0185

Chongqing, Chongqing Municipality 400030

China

Local Institution - 0184

Guangzhou, Guangdong 510060

China

Local Institution - 0152

Xinxiang, Henan 453100

China

Shanghai GoBroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality 200131

China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 201321

China

Local Institution - 0078

Dijon, Côte-d'Or 21079

France

Local Institution - 0075

Pierre-Bénite, Rhône 69310

France

Local Institution - 0116

Villejuif, Val-de-Marne 94800

France

Local Institution - 0074

Paris, 75010

France

Local Institution - 0081

Mainz, Rhineland-Palatinate 55131

Germany

Local Institution - 0040

Hamburg, 20246

Germany

Local Institution - 0039

Heidelberg, 69120

Germany

Local Institution - 0061

Leipzig, 04103

Germany

Local Institution - 0049

München, 81675

Germany

Local Institution - 0047

Würzburg, 97080

Germany

Local Institution - 0150

Hksar, 999077

Hong Kong

Local Institution - 0063

Shatin, NT

Hong Kong

Local Institution - 0080

Cork, T12 E8YV

Ireland

Local Institution - 0023

Dublin, 7

Ireland

Local Institution - 0146

Dublin, D08 E9P6

Ireland

Local Institution - 0073

Siena, Tuscany 53100

Italy

Local Institution - 0123

Bergamo, 24127

Italy

Local Institution - 0034

Milan, 20133

Italy

Local Institution - 0050

Naples, 80131

Italy

Local Institution - 0082

Perugia, 06156

Italy

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

Local Institution - 0171

Bergen, Hordaland 5021

Norway

Local Institution - 0022

Oslo, 0450

Norway

Local Institution - 0004

Seoul, Seoul-teukbyeolsi [Seoul] 03080

South Korea

Local Institution - 0058

Seoul, Seoul-teukbyeolsi [Seoul] 03722

South Korea

Local Institution - 0052

Seoul, Seoul-teukbyeolsi [Seoul] 05505

South Korea

Local Institution - 0068

Barcelona, Barcelona [Barcelona] 08035

Spain

Local Institution - 0071

Hospitalet, Barcelona [Barcelona] 08907

Spain

Local Institution - 0033

Madrid, 28028

Spain

Local Institution - 0069

Seville, 41013

Spain