Leap Therapeutics Completes Enrollment in DeFianCe Study Part B for Colorectal Cancer Treatment

Leap Therapeutics, Inc., a biotechnology firm specializing in targeted and immuno-oncology therapeutics, has completed the enrollment of 188 patients for Part B of its DeFianCe study. This Phase 2 global study assesses the efficacy of the company's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with standard care treatments, including bevacizumab and chemotherapy, for advanced colorectal cancer (CRC) patients who have undergone one prior treatment.

Cynthia Sirard, M.D., the Chief Medical Officer of Leap, highlighted the significance of this milestone, citing the enthusiasm from both patients and healthcare providers regarding DKN-01's potential. Part A of the study demonstrated promising results, including meaningful response rates and sustained tumor reduction, alongside a favorable safety profile in patients with advanced CRC. These outcomes have set a robust foundation for the extended Part B of the study. Leap Therapeutics anticipates sharing preliminary data from Part B, focusing particularly on patients with left-sided CRC, around mid-2025.

The DeFianCe study (NCT05480306) is structured as an open-label trial, combining DKN-01 with bevacizumab and chemotherapy. It aims to evaluate patients with advanced CRC who have already received one systemic therapy for their condition. Originally designed for 130 patients, Part B expanded to include 188 participants. The primary objective of this segment is to measure progression-free survival (PFS), with a specific interest in a subpopulation of individuals with left-sided CRC. Secondary goals include assessing the objective response rate, the duration of response, and overall survival.

Leap Therapeutics, listed on Nasdaq under the ticker LPTX, is dedicated to creating targeted and immuno-oncology treatments. Its leading clinical candidate, DKN-01, is a humanized monoclonal antibody focused on the DKK1 protein. DKN-01 is currently being studied in patients experiencing esophagogastric, gynecologic, and colorectal cancers.