MRTX1133 for Solid Cancers

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, MRTX1133, for individuals with certain solid tumors that have a specific gene change known as the KRAS G12D mutation. The goal is to determine if MRTX1133 can shrink or halt the growth of these tumors. The trial seeks participants with advanced cancer that cannot be surgically removed and who have already tried standard treatments. Those with a confirmed tough-to-treat solid tumor with this mutation might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants could be among the first to receive it.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that MRTX1133 is likely to be safe for humans?

Research shows that MRTX1133 holds promise for treating cancers with a KRAS G12D mutation. It has demonstrated strong anti-tumor effects in lab and animal studies, particularly for pancreatic cancer. The studies aim to assess the treatment's safety and patient tolerance, meaning how patients handle the treatment without serious side effects.

Currently, detailed safety information for humans is still being collected, as this trial is in its early stages. This phase focuses on determining the best dose and closely monitoring any side effects. Although complete safety results for humans are not yet available, careful observation is essential when testing a new treatment in people for the first time. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

MRTX1133 is unique because it specifically targets the KRAS G12D mutation, a common driver in several tough-to-treat cancers like non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC). Most current treatments for these cancers, such as chemotherapy and targeted therapies, do not directly address this specific mutation. Researchers are excited about MRTX1133 because it offers a new mechanism of action by homing in on this genetic mutation, potentially leading to more effective and personalized treatments for patients with these hard-to-treat cancers.

What evidence suggests that MRTX1133 might be an effective treatment for solid cancers with a KRAS G12D mutation?

Studies have shown that MRTX1133 effectively targets cancer cells with a KRAS G12D mutation, commonly found in pancreatic cancer. In lab tests, MRTX1133 stopped these cancer cells from growing and even shrank tumors in animals. The drug blocks a specific protein essential for the growth of these cancer cells. Research indicates that MRTX1133's effectiveness relies on T-cells, a type of immune cell. Overall, early results suggest that MRTX1133 could be a promising treatment for tumors with the KRAS G12D mutation. Participants in this trial will receive MRTX1133, with the study including dose escalation and evaluation phases, followed by a phase where the recommended dose is administered to separate cohorts of patients with selected solid tumor malignancies. ^{1 2 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922474/

A small molecule with big impact: MRTX1133 targets the ... MRTX1133 has demonstrated potent in vitro and in vivo antitumor efficacy against KRAS G12D -mutant cancer cells, especially in PDAC.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05737706

NCT05737706 | Study of MRTX1133 in Patients With ... A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

3. biorxiv.org biorxiv.org/content/10.1101/2025.09.09.674973v1.full-text

MRTX1133 is a potent non-covalent KRAS (G12C) inhibitor ... We found robust inhibition of MIA PaCa-2 proliferation after 3 days of treatment with an IC50 comparable to the 2D assay (Figure 3C), but with ...

4. aacrjournals.org aacrjournals.org/cancerdiscovery/article/13/2/298/716288/Efficacy-of-a-Small-Molecule-Inhibitor-of-KrasG12D

Efficacy of a Small-Molecule Inhibitor of Kras G12D in ... T cells were necessary for MRTX1133's full antitumor effect, and T-cell depletion accelerated tumor regrowth after therapy. These results ...

5. jgo.amegroups.org jgo.amegroups.org/article/view/89054/html

MRTX1133's promise for treating KRAS G12D -mutant ... Finally, this publication provides a detailed assessment of MRTX1133's potential for developing KRAS-targeted PDAC therapy and the problems ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20550189

Study of MRTX1133 in Patients With Advanced Solid ... The purpose of this study is to characterize the safety and tolerability of MRTX1133 as monotherapy or combined with cetuximab in patients with advanced KRAS G ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11399858/

MRTX1133's promise for treating KRASG12D-mutant ... A small molecule with big impact: MRTX1133 targets the KRAS G12D mutation in pancreatic cancer in Clin Cancer Res, volume 30 on page 655.

8. careacross.com careacross.com/clinical-trials/trial/NCT05737706

Study of MRTX1133 in Patients With Advanced Solid ... Summary: A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation. ... safety and PK information, and early evidence of clinical ...