Treating Advanced Solid Tumors with Specific RAS Mutations

About the Study

This is a Phase 1/2 clinical trial studying an experimental drug called RMC-6236 in adults with advanced solid tumors. The study is evaluating the safety of the drug, how the body processes it, and whether it can help shrink tumors.

RAS proteins help control how cells grow and divide. Changes (mutations) in genes that make RAS proteins can cause these proteins to send signals that allow cancer cells to grow and survive. Mutations in the KRAS, NRAS, and HRAS genes are found in several types of cancer, including pancreatic, colorectal, and non-small cell lung cancers.

RMC-6236 is an experimental targeted therapy designed to block active RAS proteins, including certain forms of KRAS, NRAS, and HRAS. By blocking these signals, the drug may slow or stop cancer cell growth.

What the Study Involves

• Participants will take the study drug, RMC-6236, by mouth once a day. The dose will depend on the group they are enrolled in and the phase of the study.
• Participants will have regular study visits and monitoring, which may include physical exams, blood tests, imaging scans, and tumor testing or biopsies.

In order to participate, people must have the following:

• Have an advanced solid tumor confirmed by testing of a tumor sample, including pancreatic, colorectal, and non-small cell lung cancers.
• Have a specific KRAS G12 mutation for the dose-escalation group, or a RAS mutation for certain dose-expansion or optimization groups. Some study groups include people with pancreatic cancer that does not have a RAS mutation.
• Have not received cancer treatment or have received standard treatment appropriate for their cancer type and stage.
• Are fully active or able to do light activities and are up and about most of the day.

People who: 

• Have a primary tumor of the brain or central nervous system.
• Have active brain metastases that have not been treated.
• Have a gastrointestinal condition that could prevent them from swallowing or absorbing the study drug.
• Have another unstable or significant medical condition that, in the study doctor's opinion, could make participation unsafe or prevent them from completing the study requirements.