Study Of MRTX1133 In Patients With Advanced Solid Tumors Harboring A KRAS G12D Mutation

Overview

About this study

The purpose of this study is to characterize the safety and tolerability of MRTX1133 as monotherapy or combined with cetuximab in patients with advanced KRAS G12D-mutant solid tumors, and to evaluate the pharmacokinetics (PK) of MRTX1133.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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:
    • 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.

Exclusion 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.

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions