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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental RMC-9805 monotherapy arm |
Dose exploration and dose expansion |
|
|
Experimental RMC-9805 plus RMC-6236 combination arm |
Dose exploration and dose expansion |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
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.