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Recruiting Phase 1

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

About this study

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Condition
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
Tested
RMC-9805, RMC-6236
Sponsor
Revolution Medicines, Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors
  • Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
  • ECOG performance status 0 or 1
  • Adequate organ function

Exclusion 5

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
  • Other inclusion/exclusion criteria may apply.

Where

17 sites, 17 recruiting

Johns Hopkins University

Baltimore, Maryland, United States

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, United States

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Recruiting

The Christ Hospital

Cincinnati, Ohio, United States

Recruiting

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, United States

Recruiting

Duke Cancer Center

Durham, North Carolina, United States

Recruiting

and 11 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.