Evaluating RMC-6291 and RMC-6236 for Advanced KRAS G12C Mutant Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1b study aims to assess the safety, tolerability, and pharmacokinetics of RMC-6291 in combination with RMC-6236 in adults with advanced KRAS G12C-mutated solid tumors. The study is divided into two parts: a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to evaluate preliminary antitumor activity. Participants will include those with non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma who have previously undergone treatment. The study seeks to provide insights into effective treatment options for this specific mutation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  i. 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

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

Where it's running

• UC IRVINE Health
  Orange, California, United States Recruiting
• UC Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Stanford Cancer Institute
  Stanford, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Moffitt Cancer Center and Research Institute
  Tampa, Florida, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Revolution Medicines, Inc.
• Email: medinfo@revmed.com
• Phone: 1-844-2-REVMED

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

• IBI3028 in advanced solid tumors

  This phase 1 study tests IBI3028 in adults with unresectable or metastatic solid tumors to see if it is safe and how patients tolerate it.

  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

• PET scan using [18F]FPyQCP to image fibroblast activation protein in several cancers

  This test tries a new PET imaging tracer, [18F]FPyQCP, to see if it helps detect colorectal, gastric, pancreatic ductal adenocarcinoma, invasive lobular breast, and epithelial ovarian cancers in adults.

  Recruiting Phase 1/2 Blue Earth Diagnostics · New York, New York and 1 other locations · NCT07432633

• Targeted radioligand [177Lu]Lu-DFC413 for advanced pancreatic, lung, breast, and colorectal cancers

  This will test a new targeted radioactive medicine, [177Lu]Lu-DFC413 (with a PET tracer [68Ga]Ga-NNS309), to see if it is safe and shows activity in adults with advanced pancreatic, lung, breast, or colorectal cancer.

  Recruiting at 9 sites Phase 1 Novartis · Princeton, New Jersey and 8 other locations · NCT07261631

• STRO-004 treatment in adults with recurrent or metastatic solid tumors

  This study will test whether STRO-004, alone and with pembrolizumab, is safe and can shrink tumors in adults with several types of metastatic cancers that often express Tissue Factor.

  Recruiting at 9 sites Phase 1 Sutro Biopharma, Inc. · San Diego, California and 8 other locations · NCT07227168

• GEH300079 (68Ga) PET/CT scan to detect peritoneal carcinomatosis in colorectal, gastric, ovarian, and pancreatic cancers (PERISCOPE)

  This will test whether a GEH300079 (68Ga) PET/CT scan can detect peritoneal carcinomatosis in adults with colorectal, gastric, ovarian, or pancreatic ductal adenocarcinoma who have known or suspected peritoneal disease.

  Recruiting Phase 2/3 GE Healthcare · Grand Rapids, Michigan and 1 other locations · NCT07219238

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.