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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2026-04-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors With Homozygous MTAP Deletion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

BMS-986504

Intervention Type DRUG

Specified dose on specified days

[14C]-BMS-986504

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986504

Specified dose on specified days

Intervention Type DRUG

[14C]-BMS-986504

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No