RECRUITING

Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

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Conditions

Non-Small Cell Lung Cancer (NSCLC)Colorectal CancerPancreatic Ductal AdenocarcinomaRMC-6291RAS (ON)KRASKRASG12CKRASG12C (ON)Targeted therapyMetastatic CancerLung CancerLung NeoplasmsThoracic NeoplasmsNon-small Cell Lung CancerCarcinoma, Non-Small Cell LungNSCLCColonic NeoplasmsCRCAppendiceal CancerKRAS mutationSTK11/LKB1KEAP1Bronchial neoplasmsRespiratory tract neoplasmsNeoplasms by siteNeoplasmsColon CancerRectal CancerLung diseaseRespiratory tract diseasesPancreatic CancerCarcinoma, Pancreatic DuctalPDACGastrointestinal NeoplasmsIntestinal NeoplasmsEsophageal CancerAmpullary CancerGastric CancerGynecological CancerOvarian CancerEndometrial CancerRMC-6236

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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, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Official Title

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

Quick Facts

Study Start:2023-11-14
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06128551

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 to 125 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age
  2. * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
  3. 1. Part 1. Dose Escalation: solid tumors, previously treated
  4. 2. Part 2. Dose Expansion:
  5. * ECOG performance status 0 or 1
  6. * Adequate organ function
  1. * Primary central nervous system (CNS) tumors
  2. * Active brain metastases
  3. * Known impairment of GI function that would alter the absorption
  4. * Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment

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)

City of Hope
Duarte, California, 91010
United States
UC IRVINE Health
Orange, California, 92868
United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Stanford Cancer Institute
Stanford, California, 94305
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Cancer
Detroit, Michigan, 48202
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
Columbia University
New York, New York, 10032
United States
NYU Langone Health
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104
United States
Sarah Cannon Research Institue
Nashville, Tennessee, 37203
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
MD Anderson
Houston, Texas, 77030
United States
NEXT Dallas
Irving, Texas, 75039
United States
NEXT Oncology San Antonio
San Antonio, Texas, 78229
United States
START Texas
San Antonio, Texas, 78229
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
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 Date2023-11-14
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2023-11-14
Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

  • 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
  • RMC-6236

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma