Leap Therapeutics to Present Final DeFianCe Phase 2 Results for Sirexatamab in Advanced Colorectal Cancer at ESMO 2025
核心洞察
Leap Therapeutics will present final clinical results from the DeFianCe Phase 2 study evaluating sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus standard care in advanced microsatellite stable colorectal cancer (搜索).
The randomized trial tested sirexatamab, an anti-DKK1 (搜索) monoclonal antibody, as second-line therapy in patients who received one prior systemic treatment for advanced disease.
Results will be presented at the European Society for Medical Oncology Congress 2025 in Berlin on October 19, highlighting potential advances in colorectal cancer (搜索) treatment.
Leap Therapeutics, Inc. (Nasdaq: LPTX) announced it will present final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 randomized trial evaluating sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy alone in patients with advanced microsatellite stable (MSS) colorectal cancer (搜索) who have received one prior systemic therapy for advanced disease.
The presentation will take place during a Mini Oral Session at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, scheduled for October 17-21, 2025.
Study Design and Patient Population
The DeFianCe trial represents a randomized Phase 2 study comparing sirexatamab in combination with bevacizumab and chemotherapy (Sirexatamab Arm) against the standard control arm of bevacizumab and chemotherapy alone. The study specifically enrolled patients with advanced microsatellite stable colorectal cancer (搜索) who had received one prior systemic therapy for advanced disease, positioning the experimental treatment as a second-line therapeutic option.
Therapeutic Mechanism
Sirexatamab (DKN-01) is a humanized monoclonal antibody that targets the Dickkopf-1 (搜索) (DKK1 (搜索)) protein. The drug represents part of Leap Therapeutics' focused pipeline of targeted and immuno-oncology therapeutics, which also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15 (搜索)) protein.
Conference Presentation Details
The final results will be presented by Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA, during a Mini Oral Session categorized under GI Tumours, Lower Digestive. The presentation is scheduled for Sunday, October 19, 2025, at 4:05 p.m. CEST in the Cologne Auditorium – CityCube A, with abstract number LBA34.
Company Strategic Context
The presentation comes as Leap Therapeutics has indicated plans to reduce clinical and operational activities, reduce spending and conserve cash while exploring strategic alternatives to preserve and maximize shareholder value. The company has noted its intention to potentially sell or partner sirexatamab or FL-501 as part of these strategic considerations.