A Study to Evaluate the Mass Balance, Metabolism, Elimination, and Drug Levels of [14C]-BMS-986504 (MRTX1719) in Participants With Advanced Solid Tumors With Homozygous Methylthioadenosine Phosphorylase Deletion

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors With Homozygous MTAP Deletion

Treatments: Drug: [14C]-BMS-986504; Drug: BMS-986504

Study type: Interventional

Funder types: Industry

Identifiers

NCT06672523

CA240-0008

Details and patient eligibility

About

The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in participants with advanced solid tumors with homozygous methylthioadenosine phosphorylase deletion.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants must have an advanced, unresectable, or metastatic solid tumor malignancy with a deletion of the methylthioadenosine phosphorylase (MTAP) gene.
• Participants must have received, be refractory to, be ineligible for, or be intolerant of available standard care for their cancer.

Exclusion Criteria

• Participants must not have a history of any surgical or medical conditions possibly affecting how the study drug is distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
• Participants must not have participated in a clinical study involving a radiolabeled study drug within 12 months prior to admission to the research center.
• Participants must not have a current or recent (within 3 months of study drug administration) gastrointestinal disease.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

[14C]-BMS-986504 followed by BMS-986504 Monotherapy

Experimental group

Description:

Part A: Participants will receive a single oral dose of radiolabeled \[14C\]-BMS-986504 on C1D1. Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.

Treatment:

Drug: BMS-986504

Drug: [14C]-BMS-986504