Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCSF
Dates
study started
completion around

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

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
  • 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

  • UC Irvine Cancer Center accepting new patients
    Orange California 92868 United States
  • UC Davis Cancer Center accepting new patients
    Sacramento California 95817 United States
  • UCSF accepting new patients
    San Francisco California 94158 United States

Details

Status
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