A Phase I 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

Study Identifier:
CA240-0008
CT.gov Identifier:
NCT06672523
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-515518-41-00
Study Contact Information:
N/A
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: [14C]-BMS-986504 followed by BMS-986504 Monotherapy
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  • Drug: Part B: Participants will receive non-radiolabeled BMS-986504, starting from C1D1 and until criteria for treatment discontinuation are met.
  • Drug: Intervention/Treatment
  • Drug: Drug: [14C]-BMS-986504
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • 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
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START La Rioja
    Logroño, La Rioja, Spain, 26006
    Investigator
    Maria de Miguel
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor