MRTX1719 for Solid Tumors

Recruiting at 36 trial locations

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

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

What is the purpose of this trial?

This trial is testing a new drug, MRTX1719, for patients with advanced cancers that have a specific genetic deletion. The drug aims to kill cancer cells by exploiting a weakness caused by this genetic change.

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced solid tumors that can't be surgically removed and have a specific genetic change called MTAP deletion. Participants must have tried standard treatments without success, be in fairly good health, and able to perform daily activities with ease or only slight difficulty.

Inclusion Criteria

My cancer has worsened despite receiving all standard treatments.

My cancer has a specific genetic change called MTAP deletion.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have not had major surgery in the last 4 weeks.

I have heart problems.

I have active brain metastases or carcinomatous meningitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation/Evaluation

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

8-12 weeks

Phase 1b Expansion

Implementation of expansion cohorts to ensure safety, PK information, and early evidence of clinical activity

12-16 weeks

Phase 2

Evaluation of clinical activity and efficacy of MRTX1719 in separate cohorts by histological diagnosis

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• MRTX1719

Trial Overview The study tests MRTX1719's safety and effectiveness against various solid tumors with the MTAP deletion. It's an early-stage trial (Phase 1/2), where researchers also look at how the body processes the drug and its impact on tumor size.

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

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD