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TerminatedPhase 1NCT05737706
Official study title

Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

Study summary

A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMRTX1133

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 Apr 6, 2025 · 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?14 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: MRTX1133
02
Explore related studies

How this study is categorized

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

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
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 harboring KRAS G12D mutation in tumor tissue or ctDNA.
  • Unresectable or metastatic disease.
  • Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
  • Presence of tumor lesions to be evaluated per RECIST v1.1: 1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease. 2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.
  • Age ≥ 18 years
Reasons someone may not be able to joinExclusion criteria
  • Active brain metastases or carcinomatous meningitis.
  • Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only).
  • History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • History of malignant small bowel obstruction.
  • Cardiac abnormalities.

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 - 311Phoenix, Arizona
  • Local Institution - 309New Haven, Connecticut
  • Local Institution - 301Lady Lake, Florida
  • Local Institution - 306Baltimore, Maryland
  • Local Institution - 308Boston, Massachusetts
  • Local Institution - 310Boston, Massachusetts
  • Local Institution - 314Grand Rapids, Michigan
  • Local Institution - 312New York, New York
  • Local Institution - 303Nashville, Tennessee
  • Local Institution - 302Houston, Texas
  • Local Institution - 304San Antonio, Texas
  • Local Institution - 313San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2025. Always confirm current availability with the study team.

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