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

Revolution Medicines

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: RMC-6236; Drug: RMC-9805

Study type: Interventional

Funder types: Industry

Identifiers

NCT06040541

RMC-9805-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 444 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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444 participants in 2 patient groups

RMC-9805 monotherapy arm

Experimental group

Description:

Dose exploration and dose expansion

Treatment:

Drug: RMC-9805

RMC-9805 plus RMC-6236 combination arm

Experimental group

Description:

Dose exploration and dose expansion

Treatment:

Drug: RMC-9805

Drug: RMC-6236