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

Purpose

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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Advanced Solid Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 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 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The monotherapy arm of RMC-9805; the combination arm of RMC-9805 plus RMC-6236
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RMC-9805 monotherapy arm 		Dose exploration and dose expansion
  • Drug: RMC-9805
    Oral Tablets
Experimental
RMC-9805 plus RMC-6236 combination arm 		Dose exploration and dose expansion
  • Drug: RMC-9805
    Oral Tablets
  • Drug: RMC-6236
    Oral Tablets

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Revolution Medicines, Inc.

Study Contact

Revolution Medicines, Inc.
(650) 779-2300
CT-inquiries@RevMed.com

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a 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 arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.