TerminatedPhase 1NCT05578092
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMRTX0902 and MRTX849

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 19, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Mirati Therapeutics Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Mirati Therapeutics Inc.
Interventions being studied
Drug: MRTX0902; Drug: MRTX849
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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. 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Local Institution - 001-108New Haven, Connecticut
  • Local Institution - 001-119Newark, Delaware
  • Local Institution - 001-111Orlando, Florida
  • Local Institution - 001-103Baltimore, Maryland
  • Local Institution - 001-110Rochester, Minnesota
  • Local Institution - 001-115Hackensack, New Jersey
  • Local Institution - 001-106Cincinnati, Ohio
  • Local Institution - 001-109Portland, Oregon
  • Local Institution - 001-116Pittsburgh, Pennsylvania
  • Local Institution - 001-101Nashville, Tennessee
  • Local Institution - 001-102Nashville, Tennessee
  • Local Institution - 001-112Dallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 19, 2026. Always confirm current availability with the study team.

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