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) — USA Trial Details

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)

Facility	City	Region	Status
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
Local Institution - 0085	Houston	Texas	Not Yet 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
Local Institution - 0148	Brussels	Bruxelles-Capitale, Région de	Not Yet Recruiting
Local Institution - 0114	Ghent	Oost-Vlaanderen	Not Yet 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
Local Institution - 0074	Paris	France	Not Yet Recruiting
Local Institution - 0081	Mainz	Rhineland-Palatinate	Not Yet Recruiting
Universitaetsklinikum Hamburg	Hamburg	Germany	Recruiting
Local Institution - 0039	Heidelberg	Germany	Not Yet Recruiting
Local Institution - 0061	Leipzig	Germany	Not Yet Recruiting
Local Institution - 0049	München	Germany	Not Yet 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.

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