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:
2.02452E+11
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.
Phase 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 Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Status
Recruitment Complete
Condition(s) Treated at Site
Solid Tumor