Part 1 is now complete. Enrollment is open in part 2 of this Phase 2 study.
Microsatellite stable colorectal cancer (MSS CRC)
Colorectal cancer is a term used to describe cancers that start either in the colon or the rectum. These cancers can also be referred to as colon cancer or rectal cancer, depending on where they originate and are often grouped together because they have many features in common. More than 135,000 people will get colorectal cancer in the United States this year. About one in 21 men and one in 23 women will get the disease during their lifetimes.
Colorectal cancer is the third leading cause of cancer death in women, and the second leading cause of cancer death in men. However, the death rate from colorectal cancer has been dropping steadily over the last few decades, most likely due to better screening and treatment.
Clinical Trial Description:
This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to determine the maximum tolerated dose (MTD) of eFT508 (tomivosertib) and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 (tomivosertib) at the recommended dose in combination with avelumab or eFT508 (tomivosertib) monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics (PD).