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

A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]-BMS-986504 (MRTX1719) in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

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 Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors With Homozygous MTAP Deletion
• Intervention / Treatment: Drug: BMS-986504; Drug: [14C]-BMS-986504

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Hungary
  • Budapest, Hungary, 1076
    • Recruiting
    • ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely
    • Contact: Zsuzsanna Papai, Site 0001; Phone Number: +36308281059
• Spain
  • Logroño, Spain, 26006
    • Recruiting
    • START Rioja, The START Center for cancer research
    • Contact: Maria De Miguel, Site 0004; Phone Number: +34955013068
  • Madrid, Spain, 28050
    • Recruiting
    • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid,
    • Contact: Irene Moreno Candilejo, Site 0003; Phone Number: 917567800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [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.	Drug: BMS-986504; Specified dose on specified days; Drug: [14C]-BMS-986504; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 deaths	Up to 2 years
Number of participants with laboratory abnormalities	Up to 2 years
Number of participants with drug-related AEs	Up to 2 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): October 25, 2027
• Study Completion (Estimated): October 25, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Distribution; Metabolism; Elimination; Excretion; Radiolabeled; Absorption, distribution, metabolism, and excretion (ADME); Protein arginine methyltransferase (PRMT5); Methylthioadenosine-cooperative PRMT5 inhibitor; Homozygous methylthioadenosine phosphorylase (MTAP) deletion; Mass balance study; Drug absorption
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CA240-0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No