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Clinical Trials in Japan / NCT07492680
Recruiting Phase 2

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)

NCT07492680 · tracked via the Priya Life Science Japan tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2
Started
2026-07-27
Last updated
2026-10-06

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

BMS-986504 →Daraxonrasib →Nivolumab + Relatlimab FDC →Temozolomide →Pumitamig →Pemetrexed →Carboplatin →Nab-paclitaxel →Gemcitabine →Paclitaxel →

BMS-986504: Specified dose on specified days

Daraxonrasib: Specified dose on specified days

Nivolumab + Relatlimab FDC: Specified dose on specified days

Temozolomide: Specified dose on specified days

Pumitamig: Specified dose on specified days

Pemetrexed: Specified dose on specified days

Carboplatin: Specified dose on specified days

Nab-paclitaxel: Specified dose on specified days

Gemcitabine: Specified dose on specified days

Paclitaxel: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part 1: Number of participants who achieve Objective Response (OR) — Up to approximately 2 years
    OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1
  • Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria — Up to approximately 2 years
  • Part 2: Number of participants with adverse events (AE) — Up to approximately 2 years
  • Part 2: Number of participants with Serious AEs (SAEs) — Up to approximately 2 years
  • Part 2: Number of participants with treatment related AEs — Up to approximately 2 years
  • Part 2: Number of participants with treatment related SAEs — Up to approximately 2 years
  • Part 2: Number of participants with AEs leading to study treatment discontinuation — Up to approximately 2 years
  • Part 2: Number of participants with AEs leading to death — Up to approximately 2 years
  • Part 2: Number of participants with laboratory abnormalities — Up to approximately 2 years

Trial sites (58)

FacilityCityRegionStatus
Local Institution - 0096 San Francisco California Not Yet Recruiting
Local Institution - 0182 Aurora Colorado Not Yet Recruiting
Emory University - Winship Cancer Institute Atlanta Georgia Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Local Institution - 0124 Boston Massachusetts Not Yet Recruiting
Local Institution - 0119 Ann Arbor Michigan Not Yet Recruiting
Local Institution - 0129 Rochester Minnesota Not Yet Recruiting
Local Institution - 0174 Rochester Minnesota Not Yet Recruiting
Local Institution - 0181 Rochester Minnesota Not Yet Recruiting
Local Institution - 0142 Buffalo New York Not Yet Recruiting
Local Institution - 0170 New York New York Not Yet Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Local Institution - 0100 Durham North Carolina Not Yet Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Local Institution - 0086 Seattle Washington Not Yet Recruiting
Local Institution - 0134 Madison Wisconsin Not Yet Recruiting
UZ Brussel Brussels Bruxelles-Capitale, Région de Recruiting
Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale, Région de Recruiting
UZ Gent Ghent Oost-Vlaanderen Recruiting
Local Institution - 0051 Vancouver British Columbia Not Yet Recruiting
Local Institution - 0021 Toronto Ontario Not Yet Recruiting
Local Institution - 0007 Toronto Ontario Not Yet Recruiting
Local Institution - 0155 Beijing Beijing Municipality Not Yet Recruiting
Local Institution - 0185 Chongqing Chongqing Municipality Not Yet Recruiting
Local Institution - 0184 Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Henan Medical University Xinxiang Henan Recruiting
Shanghai GoBroad Cancer Hospital China Pharmaceutical University Shanghai Shanghai Municipality Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Local Institution - 0078 Dijon Côte-d'Or Not Yet Recruiting
Local Institution - 0075 Pierre-Bénite Rhône Not Yet Recruiting
Local Institution - 0116 Villejuif Val-de-Marne Not Yet Recruiting
Hôpital Saint-Louis Paris France Recruiting
Local Institution - 0081 Mainz Rhineland-Palatinate Not Yet Recruiting
Universitaetsklinikum Hamburg Hamburg Germany Recruiting
Local Institution - 0039 Heidelberg Germany Not Yet Recruiting
Universitaetsklinikum Leipzig Leipzig Germany Recruiting
Klinikum Rechts der Isar der Technischen Universitaet Muenchen München Germany Recruiting
Local Institution - 0047 Würzburg Germany Not Yet Recruiting
Local Institution - 0150 Hksar Hong Kong Not Yet Recruiting
Local Institution - 0063 Shatin Hong Kong Not Yet Recruiting

+ 18 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in Japan

A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9) Recruiting
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS). Recruiting
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors Recruiting
A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission Active, not recruiting
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2) Active, not recruiting

Other trials for the same condition

A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors Active, not recruiting
Study of INCB123667 in Subjects With Advanced Solid Tumors Active, not recruiting
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors Active, not recruiting
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma Recruiting
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07492680 on ClinicalTrials.gov ↗ ← All trials in Japan