A Phase 1/2 Study of FOG-001 in People With Advanced Cancer

Share

Full Title

A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors

Purpose

Researchers want to find the best dose of FOG-001 to use in people with advanced cancer. This study focuses on people who have colorectal and other digestive cancers that spread and keep growing after treatment.

Digestive cancers, especially colorectal cancer, often have mutations (changes) in the Wnt protein pathway. This pathway has many roles in our bodies, including supporting the lining of the bowel. Wnt mutations may be the first step in the development of colorectal cancer and can cause cancer cells to grow.

FOG-001 may help people with cancer because it blocks the beta-catenin protein. This protein promotes cancer growth in people who have cancer with a Wnt pathway mutation. By blocking the beta-catenin protein, FOG-001 may help slow or stop the growth of your cancer. FOG-001 is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have an advanced cancer with a mutation in the Wnt protein pathway and has spread despite treatment.
  • Have recovered from the serious side effects of treatment before getting FOG-001.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Rona Yaeger’s office at 646-888-5109.

Protocol

24-043

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05919264