MRTX1719 for Solid Tumors

Recruiting at 22 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must not be taking: PRMT5, MAT2A inhibitors

Disqualifiers: Brain metastases, Hemorrhage, Cardiac abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced solid tumors, like stomach cancer or lung cancer, that can't be removed by surgery and have a specific genetic change called MTAP deletion. Participants must be able to take oral medication and have measurable disease.

Inclusion Criteria

My tumor can be biopsied unless deemed unsafe.

My cancer cannot be removed by surgery or has spread.

I am fully active or can carry out light work.

Exclusion Criteria

I have been treated with a PRMT5 or MAT2A inhibitor before.

I have heart problems.

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Exploration of MRTX1719 dose and regimen in patients with advanced solid tumors

8-12 weeks

Phase 1b Expansion

Implementation of expansion cohorts to gather safety, PK, and clinical activity data

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MRTX1719

Trial Overview The study tests MRTX1719's safety and effectiveness in treating various cancers with the MTAP deletion. It's an early-stage (Phase 1) trial where everyone gets MRTX1719 to see how well it works and what doses are safe.

Participant Groups

Group I: Phase 1b Sub-Study Experimental Treatment 1 Intervention

MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion

Group II: Phase 1/1B Experimental Treatment 1 Intervention

Dose Escalation/Evaluation

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania