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

Stopped early · Phase 1

Conditions studied: Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, Colo-rectal Cancer, Pancreatic Adenocarcinoma

In brief

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

Key facts

Study ID

NCT05737706

Run by

Mirati Therapeutics Inc.

People needed

63

Starts

2023-03-06

Expected to finish

2025-03-10

Last updated by the study team

2025-04-06

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 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:
• in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 311 — Phoenix, Arizona, United States
• Local Institution - 309 — New Haven, Connecticut, United States
• Local Institution - 301 — Lady Lake, Florida, United States
• Local Institution - 306 — Baltimore, Maryland, United States
• Local Institution - 308 — Boston, Massachusetts, United States
• Local Institution - 310 — Boston, Massachusetts, United States
• Local Institution - 314 — Grand Rapids, Michigan, United States
• Local Institution - 312 — New York, New York, United States
• Local Institution - 303 — Nashville, Tennessee, United States
• Local Institution - 302 — Houston, Texas, United States
• Local Institution - 304 — San Antonio, Texas, United States
• Local Institution - 313 — San Antonio, Texas, United States
• Local Institution - 305 — Fairfax, Virginia, United States
• Local Institution - 307 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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