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 1

Recruiting

• Conditions: Advanced Solid Tumors With Homozygous MTAP Deletion
• Interventions: Drug: BMS-986504; Drug: [14C]-BMS-986504

• Registration Number: NCT06672523
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-03-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-04-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-BMS-986504 followed by BMS-986504 Monotherapy	BMS-986504	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.
[14C]-BMS-986504 followed by BMS-986504 Monotherapy	[14C]-BMS-986504	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.

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Up to 2 weeks
Time of maximum observed drug concentration (Tmax)	Up to 2 weeks
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))	Up to 2 weeks
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to 2 weeks
Terminal elimination half-life (T-HALF)	Up to 2 weeks
Apparent total body clearance (CLT/F)	Up to 2 weeks
Apparent volume of distribution during the terminal phase (Vz/F)	Up to 2 weeks
Percentage of estimated part for the calculation of AUC(INF) (%AUC(INF))	Up to 2 weeks
Blood-to-plasma total radioactivity (TRA) ratio	Up to 2 weeks
Total amount of administered dose recovered in urine (UR)	Up to 2 weeks
Percent of administered dose recovered in urine (%UR)	Up to 2 weeks
Renal clearance (CLR) in urine	Up to 2 weeks
Total radioactivity in UR	Up to 2 weeks
Total radioactivity in %UR	Up to 2 weeks
Total radioactivity in total amount of administered dose recovered in feces (FR)	Up to 2 weeks
Total radioactivity in percent of administered dose recovered in feces (%FR)	Up to 2 weeks
Total amount of radioactivity recovered (Rtotal)	Up to 2 weeks
Total percent of radioactivity recovered (%TOTAL)	Up to 2 weeks
TRA amount recovered and fraction of the radioactive dose in vomit if applicable	Up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to 2 years
Number of participants with serious adverse events (SAEs)	Up to 2 years
Number of participants with AEs leading to discontinuation	Up to 2 years
Number of participants with drug-related AEs	Up to 2 years
Number of participants with laboratory abnormalities	Up to 2 years
Number of deaths	Up to 2 years

Trial Locations

Locations (1)

ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely; 🇭🇺 Budapest, Hungary