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

a study on Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Pancreatic Ductal Adenocarcinoma Solid Tumor Colorectal Tumor Lung Tumor Colon Cancer Appendix Cancer Neoplasms Rectal Cancer Pancreatic Cancer Pancreatic Neoplasms Pancreatic Ductal Carcinoma Gastrointestinal Cancer Esophageal Cancer Stomach Cancer Ovarian Cancer Endometrial Cancer

Summary

Eligibility
for people ages 18-125 (full criteria)
Location
at Orange 5379513, California 5332921 and other locations
Dates
study started
study ends around

Description

Summary

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.

Official Title

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

Details

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.

Keywords

Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, RMC-6291, RAS (ON), KRAS, KRASG12C, KRASG12C (ON), Targeted therapy, Metastatic Cancer, Lung Cancer, Lung Neoplasms, Thoracic Neoplasms, Non-small Cell Lung Cancer, Carcinoma, Non-Small Cell Lung, NSCLC, Colonic Neoplasms, CRC, Appendiceal Cancer, KRAS mutation, STK11/LKB1, KEAP1, Bronchial neoplasms, Respiratory tract neoplasms, Neoplasms by site, Neoplasms, Colon Cancer, Rectal Cancer, Lung disease, Respiratory tract diseases, Pancreatic Cancer, Carcinoma, Pancreatic Ductal, PDAC, Gastrointestinal Neoplasms, Intestinal Neoplasms, Esophageal Cancer, Ampullary Cancer, Gastric Cancer, Gynecological Cancer, Ovarian Cancer, Endometrial Cancer, RMC-6236, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Neoplasm Metastasis, Appendiceal Neoplasms, Rectal Neoplasms, Lung Diseases, Pancreatic Neoplasms, Pancreatic Ductal Carcinoma, Esophageal Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Assigned interventions, RMC-6291 and RMC-6236

Eligibility

You can join if…

Open to people ages 18-125

  • 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:
    3. 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

You CAN'T join if...

  • 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

Locations

  • UC IRVINE Health accepting new patients
    Orange 5379513 California 5332921 92868 United States
  • City of Hope accepting new patients
    Duarte 5344147 California 5332921 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT06128551
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 210 study participants
Last Updated
Contact us about this trial