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NCT Number: NCT06672523

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

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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Key information

Conditions

Advanced Solid Tumors With Homozygous MTAP Deletion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986504

Drug

Specified dose on specified days

[14C]-BMS-986504

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 2 weeks

  2. Time of maximum observed drug concentration (Tmax)

    Time frame: Up to 2 weeks

  3. 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

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

    Time frame: Up to 2 weeks

  5. Terminal elimination half-life (T-HALF)

    Time frame: Up to 2 weeks

  6. Apparent total body clearance (CLT/F)

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

  9. Blood-to-plasma total radioactivity (TRA) ratio

    Time frame: Up to 2 weeks

  10. Total amount of administered dose recovered in urine (UR)

    Time frame: Up to 2 weeks

  11. Percent of administered dose recovered in urine (%UR)

    Time frame: Up to 2 weeks

  12. Renal clearance (CLR) in urine

    Time frame: Up to 2 weeks

  13. Total radioactivity in UR

    Time frame: Up to 2 weeks

  14. Total radioactivity in %UR

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

  17. Total amount of radioactivity recovered (Rtotal)

    Time frame: Up to 2 weeks

  18. Total percent of radioactivity recovered (%TOTAL)

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 2 years

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 2 years

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to 2 years

  4. Number of participants with drug-related AEs

    Time frame: Up to 2 years

  5. Number of participants with laboratory abnormalities

    Time frame: Up to 2 years

  6. Number of deaths

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.