Leap Therapeutics, Inc. announced that, based on the early efficacy and momentum seen in the enrollment of 33 patients with colorectal cancer (CRC) in its DeFianCe study, it has initiated the 130 patient randomized controlled Part B of the Phase 2 study. The study evaluates Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC. The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease.

The Part A cohort enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. The study has expanded into a 130-patient Part B randomized controlled trial. The primary objective of the study is progression free survival.

Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to be able to enroll Part B in approximately 12 months and have initial data in late 2024.