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

NCT06672523 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CA240-0008
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 3

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.

Conditions

Advanced Solid Tumors With Homozygous MTAP Deletion

Keywords

Protein arginine methyltransferase (PRMT5); Methylthioadenosine-cooperative PRMT5 inhibitor; Homozygous methylthioadenosine phosphorylase (MTAP) deletion; Mass balance study; Metabolism; Elimination; Drug absorption; Distribution; Excretion; Radiolabeled; Absorption, distribution, metabolism, and excretion (ADME)

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (6)

• 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

Study Arms (1)

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

EXPERIMENTAL

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; Drug: [14C]-BMS-986504

Interventions

BMS-986504 DRUG

Specified dose on specified days

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

[14C]-BMS-986504 DRUG

Specified dose on specified days

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, 1076, Hungary

RECRUITING

START Rioja, The START Center for cancer research

Logroño, 26006, Spain

RECRUITING

Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid,

Madrid, 28050, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): October 25, 2027
• Study Completion (Estimated): October 25, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

HU (1); ES (2)