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

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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

Trial contacts and locations

16

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Central trial contact

Revolution Medicines, Inc.

Data sourced from clinicaltrials.gov

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