Leap Therapeutics Announces Initiation of Randomized Controlled Part B of the DeFianCe Study of DKN-01 in Colorectal Cancer Patients

Leap Therapeutics, a biotechnology company specializing in targeted and immuno-oncology therapeutics, has announced the initiation of Part B of the DeFianCe study for DKN-01 in colorectal cancer patients. This study aims to assess the effectiveness of Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, when combined with standard care bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer.

The initial enrollment of 33 patients in Part A of the DeFianCe study yielded promising early results, with an overall response rate exceeding 20%. Encouraged by these findings, Leap has made the decision to proceed with the randomized controlled Part B of the Phase 2 study. The company plans to enroll approximately 130 patients in Part B and anticipates having preliminary data available by late 2024.

The DeFianCe study is a global Phase 2 trial that includes patients with advanced colorectal cancer who have undergone one prior systemic therapy. The primary objective of the study is to evaluate progression-free survival, while secondary objectives