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KRAS G12D Inhibitor

MRTX1133 for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA

Must not have

Active brain metastases or carcinomatous meningitis

History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new drug to see how safe and effective it is on patients with certain types of cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an early-phase trial for MRTX1133, detailed side effects are not yet fully known but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver function alterations, and potential risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer has a KRAS G12D mutation.

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My cancer cannot be removed by surgery or has spread to other parts.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain metastases or carcinomatous meningitis.

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I have a history of serious gut issues that could affect medication absorption.

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I have had a cancer-related blockage in my small intestine.

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I have heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 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 1/1BExperimental Treatment1 Intervention

Dose Escalation/Evaluation

0 / 8Eligibility criteria met