Trial Title:
Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
NCT ID:
NCT06128551
Condition:
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Assigned interventions
Description:
Drug: RMC-6291 and RMC-6236 Oral tablets
Arm group label:
RMC-6291 and RMC-6236
Summary:
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.
Detailed description:
This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with
RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the
maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and
provide a preliminary assessment of the antitumor activity of RMC-6291 in participants
with KRASG12C tumors.
The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years of age
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic
solid tumors not amendable to curative therapy
1. Part 1. Dose Escalation: solid tumors, previously treated
2. Part 2. Dose Expansion:
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF)
inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve
to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy,
chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases
<2 cm in size iv. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
125 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UC Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Cancer Institute
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Columbia University
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Oklahoma
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institue
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley Cancer Research
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
START Texas
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
West Cancer Institute
Address:
City:
Angers
Zip:
49055
Country:
France
Status:
Recruiting
Facility:
Name:
Cancer Institute of Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Facility:
Name:
Universitäts Klinikum Köln
Address:
City:
Köln
Zip:
80937
Country:
Germany
Status:
Recruiting
Facility:
Name:
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche
Address:
City:
Ancona
Zip:
60126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Institute Romagnolo per lo Studio Tumori
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
AUSL Romagna - S.M. delle Croci Hospital
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Netherlands Cancer Institute Antoni van Leeuwenhoek
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Pan American Center for Oncology Trials
Address:
City:
San Juan
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
START Barcelona - Hospital HM Nou Delfos
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
NEXT Oncology - Quirónsalud Madrid University Hospital
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Clinic of Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
La Fe University and Polytechnic Hospital
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Start date:
November 14, 2023
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Revolution Medicines, Inc.
Agency class:
Industry
Source:
Revolution Medicines, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06128551
