RECRUITING

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Official Title

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

Quick Facts

Study Start:2023-09-07
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06040541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
  2. * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
  3. * ECOG performance status 0 or 1
  4. * Adequate organ function
  1. * Primary central nervous system (CNS) tumors
  2. * Known or suspected leptomeningeal or active brain metastases or spinal cord compression
  3. * Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  4. * Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Contacts and Locations

Study Contact

Revolution Medicines, Inc.
CONTACT
1-844-2-REVMED
medinfo@RevMed.com

Principal Investigator

Revolution Medicines, Inc.
STUDY_DIRECTOR
Revolution Medicines, Inc.

Study Locations (Sites)

University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Smilow Cancer Hospital (Yale University)
New Haven, Connecticut, 06511
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Lee Moffitt Cancer Center
Tampa, Florida, 33612
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
NYU Langone
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
START
San Antonio, Texas, 78229
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Revolution Medicines, Inc.

  • Revolution Medicines, Inc., STUDY_DIRECTOR, Revolution Medicines, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12D (ON)
  • NSCLC
  • CRC
  • PDAC
  • Non-small Cell Lung Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Colon Cancer
  • Pancreatic Cancer
  • Metastatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Neoplasms
  • Colorectal Neoplasms
  • Gastrointestinal Neoplasms
  • KRAS
  • Colonic Neoplasms

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Advanced Solid Tumors