A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

Description

This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

Conditions

Solid Tumor, Advanced Solid Tumor, Non Small Cell Lung Cancer, Colo-rectal Cancer

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Study Overview

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Study Details

Study overview

This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.

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

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06520

Washington

Local Institution - 001-113, Washington, District of Columbia, United States, 20016-2633

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827-7400

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287

Rochester

Local Institution - 001-110, Rochester, Minnesota, United States, 55905-0001

Cincinnati

University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States, 45219-2364

Portland

Local Institution - 001-109, Portland, Oregon, United States, 97239-3011

Nashville

Local Institution - 001-102, Nashville, Tennessee, United States, 37203

Nashville

Sarah Cannon Research Institute Central Office, Nashville, Tennessee, United States, 37203

Dallas

Local Institution - 001-112, Dallas, Texas, United States, 75246-2003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirati Therapeutics Inc.,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2026-07-30