MRTX1133 for Solid Cancers

Recruiting at 40 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mirati Therapeutics Inc.

Disqualifiers: Brain metastases, Hemoptysis, Intestinal disease, others

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

Compensation: Varies

Number of Visits: Unknown

63 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success, be in fairly good health and physical condition (ECOG status of 0 or 1), and their cancer should not be removable by surgery. They can't join if they've had certain gastrointestinal issues, brain metastases, previous treatment with a KRAS G12D inhibitor (for later phases), or significant bleeding recently.

Inclusion Criteria

I have received all standard treatments for my cancer type and stage.

My cancer can be measured or evaluated using specific criteria.

My organs are working well.

Exclusion Criteria

I have not had severe coughing up of blood or bleeding in the last 4 weeks.

I have previously been treated with a KRAS G12D inhibitor.

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 MRTX1133 dose and regimen in patients with advanced solid tumors

Phase 1 duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MRTX1133

Trial Overview The study is testing MRTX1133's safety and effectiveness on various types of solid tumors with the KRAS G12D mutation. It's an early-stage trial to figure out the right dose and see how well it works across different stages: first in any tumor size then focusing on measurable ones.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

MRTX1133 recommended Phase 2 dose administered to separate cohorts of patients with selected solid tumor malignancies with KRAS G12D mutation to include the following: NSCLC, PDAC, CRC, Other Solid Tumors

Group II: 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