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

Stopped early · Phase 1

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

In brief

This is a Phase 1, 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.

Key facts

Study ID

NCT05578092

Run by

Mirati Therapeutics Inc.

People needed

64

Starts

2022-12-02

Expected to finish

2026-02-03

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
• 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. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable 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

You may not qualify if…

• Active brain metastases or carcinomatous meningitis
• Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination).
• 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 it is running

• Local Institution - 001-108 — New Haven, Connecticut, United States
• Local Institution - 001-119 — Newark, Delaware, United States
• Local Institution - 001-111 — Orlando, Florida, United States
• Local Institution - 001-103 — Baltimore, Maryland, United States
• Local Institution - 001-110 — Rochester, Minnesota, United States
• Local Institution - 001-115 — Hackensack, New Jersey, United States
• Local Institution - 001-106 — Cincinnati, Ohio, United States
• Local Institution - 001-109 — Portland, Oregon, United States
• Local Institution - 001-116 — Pittsburgh, Pennsylvania, United States
• Local Institution - 001-101 — Nashville, Tennessee, United States
• Local Institution - 001-102 — Nashville, Tennessee, United States
• Local Institution - 001-112 — Dallas, Texas, United States
• Local Institution - 001-122 — Fort Worth, Texas, United States
• Local Institution - 001-107 — Houston, Texas, United States
• Local Institution - 001-123 — Tyler, Texas, United States
• Local Institution - 001-104 — Fairfax, Virginia, United States
• Local Institution - 001-105 — Seattle, Washington, United States
• Local Institution - 001-114 — Rio Piedras, Puerto Rico

Full record on ClinicalTrials.gov

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