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

Phase 1RecruitingNCT06672523

Bristol-Myers Squibb8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors With Homozygous MTAP Deletion

Interventions

BMS-986504DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax)

Time frame: Up to 2 weeks

Time of maximum observed drug concentration (Tmax)

Time frame: Up to 2 weeks

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

Time frame: Up to 2 weeks

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Time frame: Up to 2 weeks

Terminal elimination half-life (T-HALF)

Time frame: Up to 2 weeks

Apparent total body clearance (CLT/F)

Time frame: Up to 2 weeks

Apparent volume of distribution during the terminal phase (Vz/F)

Time frame: Up to 2 weeks

Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))

Time frame: Up to 2 weeks

Blood-to-plasma total radioactivity (TRA) ratio

Time frame: Up to 2 weeks

Total amount of administered dose recovered in urine (UR)

Time frame: Up to 2 weeks

Percent of administered dose recovered in urine (%UR)

Time frame: Up to 2 weeks

Renal clearance (CLR) in urine

Time frame: Up to 2 weeks

Total radioactivity in UR

Time frame: Up to 2 weeks

Total radioactivity in %UR

Time frame: Up to 2 weeks

Total radioactivity in total amount of administered dose recovered in feces (FR)

Time frame: Up to 2 weeks

Total radioactivity in percent of administered dose recovered in feces (%FR)

Time frame: Up to 2 weeks

Total amount of radioactivity recovered (Rtotal)

Time frame: Up to 2 weeks

Total percent of radioactivity recovered (%TOTAL)

Time frame: Up to 2 weeks

TRA amount recovered and fraction of the radioactive dose in vomit if applicable

Time frame: Up to 2 weeks

Secondary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to 2 years

Number of participants with serious adverse events (SAEs)

Time frame: Up to 2 years

Number of participants with AEs leading to discontinuation

Time frame: Up to 2 years

Number of participants with drug-related AEs

Time frame: Up to 2 years

Number of participants with laboratory abnormalities

Time frame: Up to 2 years

Number of deaths

Time frame: Up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts