A Phase 1a/1b Basket Trial of BMS-986504 With Standard-of-Care Therapy For Patients With Select Metastatic MTAP-deleted Solid Tumors

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Trial Details

Sponsor: Memorial Sloan Kettering Cancer Center (other)

Phase: 1

Start date: April 7, 2026

Planned enrollment: 60

Trial ID: NCT07532902
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More trial details at ClinicalTrials.gov More info

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chevron Show for: BMS-986504 (MRTX1719)

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Goal: Assess the safety of BMS-986504 combined with disease-specific standard therapy and identify a recommended phase 2 dose in MTAP-deleted advanced solid tumors.

Patients: Adults with measurable, metastatic or unresectable diffuse pleural mesothelioma, gastroesophageal carcinoma, or urothelial carcinoma and tumor-tissue confirmation of MTAP loss or deletion. Mesothelioma and gastroesophageal cohorts are generally treatment-naive in the metastatic setting; the urothelial cohort requires at least one prior line of treatment. Gastroesophageal tumors must be PD-L1 CPS ≥1 and HER2-negative. Patients must have adequate organ function and a Karnofsky performance status ≥70 or ECOG performance status of 0.

Design: Nonrandomized phase 1a/1b basket trial with three disease-specific treatment cohorts and no control arm.

Treatments: The mesothelioma cohort receives BMS-986504 with ipilimumab and nivolumab; the gastroesophageal cohort receives it with FOLFOX and nivolumab; and the urothelial cohort receives it with gemcitabine plus cisplatin or carboplatin, followed by BMS-986504 alone. BMS-986504 is an investigational oral inhibitor of the PRMT5–methylthioadenosine complex, designed to exploit methylthioadenosine accumulation caused by MTAP deletion. In a separate early-phase, nonrandomized study of previously treated MTAP-deleted solid tumors, an interim analysis reported a 23% objective response rate and 13% grade ≥3 treatment-related adverse events; these results do not establish the benefit or safety of the combinations in this trial.

Outcomes: The primary outcome is the recommended phase 2 dose, informed by adverse events and dose-limiting toxicities graded using CTCAE v5.0. Secondary outcomes are objective response rate and progression-free survival assessed by RECIST v1.1 or, where applicable for mesothelioma, modified RECIST, over two years.

Burden on patient: Likely moderate to high: combination treatment entails repeated clinic visits for intravenous chemotherapy and/or immunotherapy alongside oral BMS-986504, plus safety monitoring and response scans. Phase 1 dose-finding may require additional assessments, but the supplied information does not specify mandatory research biopsies or intensive pharmacokinetic blood draws.

Last updated: Sep 2026

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Sites (7)

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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

No email / 646-608-3763

Status: Recruiting

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

No email / 646-608-3763

Status: Recruiting

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