Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

Revolution Medicines

Status and phase: Enrolling; Phase 1

Conditions: Non-Small Cell Lung Cancer (NSCLC); Pancreatic Ductal Adenocarcinoma; Colorectal Cancer

Treatments: Drug: Assigned interventions

Study type: Interventional

Funder types: Industry

Identifiers

NCT06128551

RMC-6291-101

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Full description

This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors.

The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 125 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age

• Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

  1. Part 1. Dose Escalation: solid tumors, previously treated
  2. Part 2. Dose Expansion:

  i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2 cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.

• ECOG performance status 0 or 1

• Adequate organ function

Exclusion criteria

• Primary central nervous system (CNS) tumors
• Active brain metastases
• Known impairment of GI function that would alter the absorption
• Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

210 participants in 1 patient group

RMC-6291 and RMC-6236

Experimental group

Description:

Dose escalation and Dose expansion

Treatment:

Drug: Assigned interventions