Colon Cancer Clinical Trial

Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors

Summary

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

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Full Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.

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Eligibility Criteria

Inclusion Criteria:

Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test
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 Criteria:

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 KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

290

Study ID:

NCT06040541

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 7 Locations for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Carolina BioOncology Institute
Huntersville North Carolina, 28078, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
START
San Antonio Texas, 78229, United States
NEXT Oncology Virginia
Fairfax Virginia, 22031, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 1

Estimated Enrollment:

290

Study ID:

NCT06040541

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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