Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC) focused on measuring KRAS, Non-small Cell Lung Cancer, Lung Cancer, Colorectal Cancer, Colon Cancer, Metastatic Cancer, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, NSCLC, CRC, PDAC, Pancreatic Neoplasms, Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Colonic Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplastic Processes, Thoracic Neoplasms, Antineoplastic Agents, Melanoma, Gynecological Cancers, RAS
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed advanced solid tumor with KRAS p.G12A, KRAS p.G12D, KRAS p.G12R, KRAS p.G12S, or KRAS p.G12V mutations identified through deoxyribonucleic acid (DNA) sequencing.
- Received prior standard therapy appropriate for tumor type and stage
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function
Exclusion Criteria:
- Tumor harboring the KRAS p.G12C mutation
- Primary central nervous system (CNS) tumors
- Known or suspected leptomeningeal or brain metastases or spinal cord compression
- Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
- History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
Sites / Locations
- UC Irvine/Chao Family Comprehensive Cancer CenterRecruiting
- Dana Farber Cancer InstituteRecruiting
- Perlmutter Cancer Center at NYU Langone HealthRecruiting
- Memorial Sloan-Kettering Cancer CenterRecruiting
- Columbia UniversityRecruiting
- Christ Hospital Cancer CenterRecruiting
- Sarah Cannon Research InstituteRecruiting
- University of Texas at AustinRecruiting
- Mary Crowley Cancer ResearchRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- Next OncologyRecruiting
- Huntsman Cancer InstituteRecruiting
- Next Oncology VirginiaRecruiting
Arms of the Study
Arm 1
Experimental
Experimental: RMC-6236
Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NSCLC, PDAC, CRC, RAS mutant NSCLC, PDAC, CRC, Melanoma, gynecological cancer or other solid tumors not previously specified). RAS mutant is defined as any nonsynonymous mutation of KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)