NCT07349537

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 574 (estimated)
• Sponsor: Revolution Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

Detailed description

This is an open-label, multicenter, Phase 1/1b study of RMC-5127 in adults with advanced KRAS G12V-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: RMC-5127 monotherapy arm, RMC-5127 plus daraxonrasib combination arm, and RMC-5127 plus cetuximab combination arm. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Both parts of the monotherapy arm may include Food Effect Cohorts.

Conditions

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

Interventions

Type	Name	Description
DRUG	RMC-5127	oral tablets
DRUG	daraxonrasib	oral tablets
DRUG	cetuximab	IV infusion

Timeline

• Start date: 2026-01-08
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2026-01-16
• Last updated: 2026-02-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study