Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy 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 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around

Description

Summary

This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.

Official Title

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

Details

This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.

The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.

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, Elironrasib, Daraxonrasib, 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, Elironrasib Monotherapy, Daraxonrasib Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 18 years of age
  • Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
    1. Phase 1b Dose Escalation: solid tumors, previously treated
    2. Phase 1b Dose Expansion and Phase 2:
    3. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. 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 California 92868 United States
  • City of Hope withdrawn
    Duarte California 91010 United States
  • Stanford Cancer Institute accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT06128551
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 534 study participants
Last Updated
Contact us about this trial