A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer

Recruiting now · Phase 1

Conditions studied: Diffuse Pleural Mesothelioma, Gastroesophageal Carcinoma, Urothelial Carcinoma

In brief

The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic/advanced unresectable MTAP-deleted solid tumor cancer.

Key facts

Study ID

NCT07532902

Run by

Memorial Sloan Kettering Cancer Center

People needed

60

Starts

2026-04-07

Expected to finish

2029-04-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documentation of Disease:
• Patients must have pathologic confirmation of one of three diseases:
• Diffuse pleural mesothelioma (DPM)
• Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.
• PD-L1 CPS ≥1 (using clone 73-10, DAKO)
• HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio <2 and average HER2 copy number <6.0 signals/cell
• Urothelial carcinoma (UC)
• Archival tissue is acceptable
• Metastatic or advanced/unresectable disease:
• For Diffuse Pleural Mesothelioma (DPM) and Gastroesophageal Carcinoma (GEC )cohorts: no prior systemic treatment for metastatic disease
• Patients with metastatic disease after treatment for localized GEC may have received prior systemic therapy (chemotherapy and/or chemoradiation) if >6 months have elapsed between the end of therapy and registration.
• One prior cycle of standard-of-care therapy alone without BMS-986504 or other MTAP inhibitors (ipi/nivo for DPM, FOLFOX + nivo for GEC) is acceptable with PI approval.
• For UC cohort: must have received at least 1 prior line of treatment without prior gemcitabine (prior tx with Gem+Platinum in the perioperative setting is permitted if at least 12 months have elapsed from trial enrollment)
• Patients with recurrent disease within 1 year of completion of prior perioperative systemic therapy are eligible with PI approval.
• One prior cycle of standard-of-care therapy alone with gemcitabine + platinum, without BMS-986504 or other MTAP inhibitors, is acceptable with PI approval.
• Confirmation of MTAP deletion by either IHC or NGS:
• MTAP deletion must be detected by either IHC and/or NGS (including FACETS), done on tumor tissue (not blood):
• IHC (using antibody 1813, NBP2-75730, Novus Biologicals)30
• IHC staining showing loss of MTAP expression
• Tissue-based NGS options
• MSK-IMPACT version 7 or beyond showing homozygous MTAP copy number loss
• FACETS showing homozygous deletion
• Other CLIA-approved commercial Template Version: 1-21-25
• Full report must be available for review and confirmation
• Cases with discordant results between NGS and IHC, in which one test shows MTAP loss/MTAP del and the other shows MTAP intact, are acceptable with PI approval

You may not qualify if…

• Prior treatment with PRMT5i or MAT2Ai
• Symptomatic CNS metastases
• Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and the patient is on a stable dose of corticosteroids
• Received palliative radiation therapy within 3 days prior to initiation of study treatment or definitive SRS including CNS SRS within 14 days prior to initiation of study treatment
• Patients who have had major surgery within 3 weeks of start of study drug
• o Note: procedures such as biopsy, pleural catheter insertion, central venous catheter or other minor procedures are permitted
• Any of the following cardiac abnormalities:
• Unstable angina pectoris or myocardial infarction within 6 months prior to enrollment
• Congestive heart failure ≥ NYHA Class 3 within 6 months prior to enrollment
• Prolonged QTc > 500 milliseconds or history of Long QT Syndrome
• Child-Pugh class C liver cirrhosis
• Ongoing medical illness not otherwise listed which would preclude study at the discretion of the PI
• Inability to take medications PO (BMS-986504 cannot be taken via gastrostomy tube), refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of BMS-986504 in the opinion of the treating physician and/or PI
• Ongoing need for a medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4 and/or P-glycoprotein (P-gp) or proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry
• HIV, HBV, or HCV with detectable viral load
• For patients with known HIV, HBV, and/or HCV infection:
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable with or without suppressive therapy
• Patients with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Active infection requiring parenteral antibiotic(s)
• Pregnant or breastfeeding
• Presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Where it is running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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