MRTX1719 for Solid Tumors

Recruiting at30 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Mirati Therapeutics Inc.

Must not be taking: PRMT5, MAT2A inhibitors

Disqualifiers: Brain metastases, Hemorrhage, Cardiac abnormalities, others

No Placebo Group

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.

Trial 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 (Anti-metabolites)

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 2 Experimental Treatment 1 Intervention

MRTX1719 RP2D administered to separate cohorts of patients with selected solid tumor malignancies with MTAP homozygous deletion to include the following: Mesothelioma, Pancreatic Adenocarcinoma, NSCLC, Malignant Peripheral Nerve Sheath Tumor, Other Solid Tumors

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

Dose Escalation/Evaluation

Who Is Running the Clinical Trial?

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