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Testing MRTX0902 for solid tumors with KRAS mutations

A Phase 1/2 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway

PHASE1; PHASE2 · Mirati Therapeutics Inc. · NCT05578092

This study is testing a new drug called MRTX0902, alone and with another drug, to see if it can help people with advanced solid tumors that have KRAS mutations.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment228 (estimated)
Ages18 Years and up
SexAll
SponsorMirati Therapeutics Inc. (industry)
Locations24 sites (Colorado Springs, Colorado and 23 other locations)
Trial IDNCT05578092 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 clinical trial evaluates the safety and effectiveness of MRTX0902, both alone and in combination with MRTX849, in patients with advanced solid tumors that have mutations in the KRAS-MAPK pathway. The study begins with a dose exploration of MRTX0902, followed by a combination therapy phase once safety and pharmacokinetic data are established. Patients will be grouped based on their tumor type and characteristics to assess the clinical activity of the treatment. The trial aims to gather sufficient data to recommend further phases of treatment based on observed efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable or metastatic solid tumors that have specific KRAS or related mutations and for whom no curative treatment options are available.

Not a fit: Patients without KRAS mutations or those with tumors that are resectable or have available curative treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors harboring specific KRAS mutations.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be viable and beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test:

  1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
  2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
* Unresectable or metastatic disease
* No available treatment with curative intent; standard treatment is not available or patient declines
* Presence of tumor lesions to be evaluated per RECIST 1.1:

  1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
  2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease
* Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Active brain metastases or carcinomatous meningitis
* Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only)
* History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
* Major surgery within 4 weeks of first dose of study treatment
* History of pneumonitis or interstitial lung disease
* Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors
* Cardiac abnormalities
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications

Where this trial is running

Colorado Springs, Colorado and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumor, Advanced Solid Tumor, Non Small Cell Lung Cancer, Colo-rectal Cancer, NSCLC, Colorectal Cancer, CRC, EGFR

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.