Evaluating a new drug for advanced solid tumors with a specific genetic 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
This study is testing a new drug for people with advanced solid tumors that have a specific genetic change to see how the drug works in their bodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 3 sites (Budapest and 2 other locations) |
| Trial ID | NCT06672523 on ClinicalTrials.gov |
What this trial studies
This study evaluates the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in participants who have advanced solid tumors with a homozygous deletion of the methylthioadenosine phosphorylase (MTAP) gene. It aims to understand how the drug behaves in the body and its potential effectiveness in this specific patient population. Participants must have previously received or been intolerant to standard cancer treatments. The study is interventional and is classified as Phase 1, focusing on the pharmacokinetics of the drug.
Who should consider this trial
Good fit: Ideal candidates are individuals with advanced, unresectable, or metastatic solid tumors that have a homozygous MTAP deletion.
Not a fit: Patients without the homozygous MTAP deletion or those who have not exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have a specific genetic alteration.
How similar studies have performed: While this approach is novel in targeting the MTAP deletion, similar studies have shown promise in evaluating targeted therapies for specific genetic alterations in tumors.
Eligibility criteria
Show full inclusion / exclusion 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 * 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.
Where this trial is running
Budapest and 2 other locations
- ICON / PRA Magyarország Kft. Fázis I-es Klinikai Farmakológiai Vizsgálóhely — Budapest, Hungary (Recruiting)
- START Rioja, The START Center for cancer research — Logroño, Spain (Recruiting)
- Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.