A Phase 1-2 Study of Petosemtamab Alone or With Standard Chemotherapy in People With Advanced Colorectal Cancer

Full Title

Phase 1/2 dose escalation and cohort expansion study evaluating MCLA-158 (petosemtamab) as single agent or in combination in advanced solid tumors

Purpose

Researchers are assessing petosemtamab given alone or with standard chemotherapy in people with advanced colorectal cancer. The people in this study have colorectal cancer that is inoperable (cannot be removed with surgery) or has metastasized (spread).

Petosemtamab is a bispecific antibody. It works against cancer by binding to two proteins. One protein is on cancer cells. The other protein is on intestinal stem cells, which help renew the lining of the intestines. Intestinal cancer stem cells may help cancer cells survive therapy. Petosemtamab is also designed to help your immune system kill cancer cells.

If you join this study, you will get petosemtamab alone or with standard chemotherapy. The standard chemotherapy will be either FOLFOX (5-fluorouracil [5-FU], leucovorin, and oxaliplatin) or FOLFIRI (5-FU, leucovorin, and irinotecan). All of the medications in this study are given intravenously (by vein).

Who Can Join

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

  • Have inoperable or metastatic colorectal cancer with normal KRAS, NRAS, and BRAF genes. 
  • Have recovered from the serious side effects of previous treatments before getting the study therapy.
  • 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 and to see if you can join this study, please call Dr. Rona Yaeger’s office at 646-888-5109.

Protocol

25-175

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT03526835