Testing the addition of anti-cancer drug, ZEN003694, to the usual chemotherapy treatment, cetuximab plus encorafenib, for colorectal cancer

UVA Tracking #
Principal Investigator
Paul R Kunk
Contact Phone
Official Trial Title
A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination with Cetuximab and Encorafenib in Patients with Refractory BRAF V600E Metastatic Colorectal Cancer
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with refractory BRAF V600E Metastatic Colorectal Cancer for a research study. The purpose of this study is to test the safety of a combination of drugs called ZEN003694, cetuximab, and encorafenib. This drug combination has been tested in animals but has not been tested in people. This study tests different doses of the drug to see which dose is safer for people. Cetuximab plus encorafenib has been approved by the FDA to treat some cancers, but the drug combination with ZEN003694 is not approved by the FDA for treatment of your disease.

The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. If you decide to take part in this study, you will get ZEN003694 and encorafenib orally once a day, and cetuximab intravenously on the 1st and 15th day of a 28-day cycle until your disease gets worse, the side effects become too severe, or you withdraw from the study. After you finish your treatment, your doctor will continue to follow your condition and watch you for side effects as well as disease progression. They will check you every 2 months indefinitely by phone or clinic visits.
The investigational drug, ZEN003694, will be provided by the study at no cost to you. All additional procedures required by the study, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge.

Additional information can be found here: https://clinicaltrials.gov/study/NCT06102902



No Compensation