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This clinical trial is for men and women who have advanced cancer that may have spread locally or to other parts of the body and is known to have a mutation in a member of the RAS gene family. RAS genes make proteins inside cells that control cell growth and cell survival, and cancers with a mutated RAS gene often grow and spread more quickly and are harder to treat.
This study involves an experimental oral drug called IMM-1-104. The purpose of this study is to find out if IMM-1-104 is safe, can be tolerated in adults with advanced cancers, and whether IMM-1-104 will slow or stop cancers from growing. IMM-1-104 has not been given to, or tested in, people before this study.
Experimental means that IMM-1-104 has not yet been approved by the U.S. Food and Drug Administration (FDA). IMM-1-104 can only be given to people as part of a clinical study like this one.
IMM-1-104 belongs to a group of anti-cancer drugs called MEK (mitogen-activated protein kinase) inhibitors (blockers). MEK is a protein inside cells that relays signals which help cancer grow and spread. MEK inhibitors block these signals and therefore may help to slow or stop cancer from getting worse.
IMM-1-104 is taken by mouth daily. Each IMM-1-104 regimen cycle lasts 28 days and can continue for up to 12 cycles.
There will be two parts to this study: Phase 1 and Phase 2a. Phase 1 will focus on Dose Exploration including careful stepwise increases of doses of IMM-1-104 that groups of participants receive (dose escalation) and Phase 2a will focus on participants with specific cancers including melanoma, pancreatic cancer, lung cancer and colon cancer.
All participants will have at least weekly study visits during the first month of taking the study drug IMM-1-104. Study visits will continue every other week until participants are done taking the study drug.
The study duration for most participants is expected to be about 12 months but may be shorter or longer depending upon how the participant’s cancer responds to the study drug.
Detailed eligibility reviewed when participant contacts the study team.