This study is in progress, not accepting new patients

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C 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 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Varun Monga
Headshot of Varun Monga
Varun Monga

Description

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

Official Title

Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Details

This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Keywords

Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor, 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, Colorectal Cancer, 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, 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

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subject must be ≥18 years of age.
  • Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
  • ECOG performance status 0 or 1
  • Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and for NSCLC in dose expansion
  • 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.
  • Prior therapy with KRASG12C (ON) inhibitor

Other inclusion/exclusion criteria may apply.

Locations

  • UCSF
    San Francisco California 94158 United States
  • UC Davis Cancer Center
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Varun Monga
    Dr. Varun Monga is a Board Certified Medical Oncologist who serves as an Clinical Associate Professor of Medicine in the Division of Hematology and Oncology. He joined UCSF Medical Center in 2023 and he provides patient care services limited to UCSF Sarcoma Center and Cancer Clinical Trials and Investigational Treatments Center.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT05462717
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 222 study participants
Last Updated