Leap Therapeutics Completes Enrollment in DKN-01 Study for Cancer
Leap Therapeutics Reports Successful Completion of Patient Enrollment
Leap Therapeutics, Inc. (NASDAQ: LPTX), a biotechnology company dedicated to developing targeted and immuno-oncology therapeutics, has recently announced an important milestone in their clinical research. The company has successfully completed the enrollment of 188 patients in Part B of the DeFianCe study, which evaluates the effectiveness of DKN-01, Leap's innovative anti-Dickkopf-1 (DKK1) antibody. This study investigates its application alongside standard of care treatment, including bevacizumab and chemotherapy, for patients battling advanced colorectal cancer (CRC).
Significance of DKN-01 in Colorectal Cancer Treatment
Dr. Cynthia Sirard, the Chief Medical Officer at Leap Therapeutics, expressed her enthusiasm about the study's progress, stating, "The completion of enrollment in this phase of the DeFianCe study is not just a milestone; it showcases the confidence in DKN-01 from both patients and healthcare providers. The promising data we've gathered from Part A, which indicated significant response rates and lasting tumor reductions, lays a strong foundation for the upcoming analysis in Part B." Dr. Sirard also hinted that the initial results, especially concerning left-sided CRC patients, would be shared midway through the forthcoming year.
What is the DeFianCe Study?
The DeFianCe study, noted under clinical trial identifier NCT05480306, is a Phase 2, open-label study conducted globally. It seeks to observe the effects of DKN-01 in conjunction with bevacizumab and chemotherapy on patients who have previously undergone treatment for advanced CRC. The expanded Part B has optimized the patient recruitment from an initial 130 to 188, focusing on progression-free survival (PFS) as a primary endpoint, with an additional focus on patients with left-sided CRC.
Objectives and Goals of Part B in the DeFianCe Study
The objectives of Part B include assessing not just progression-free survival, but also evaluating the objective response rate, duration of that response, and overall survival rates among participants. These parameters are crucial for determining DKN-01's potential efficacy and safety when utilized alongside standard treatment regimens.
Leap’s Commitment to Oncology Therapeutics
Leap Therapeutics is extensively invested in advancing therapies for various forms of cancer. The company’s lead candidate, DKN-01, represents its commitment to pioneering strategies in immuno-oncology. This humanized monoclonal antibody is specifically designed to target the DKK1 protein, which is overexpressed in several tumor types, including esophagogastric, gynecologic, and colorectal cancers. By focusing on such cancers, Leap is addressing significant unmet medical needs.
Looking Ahead: Future Prospects
As Leap Therapeutics anticipates sharing data from Part B of the study, the implications for the treatment landscape in colorectal cancer could be profound. The enthusiasm from both physicians and patients provides a glimpse into the future potential of DKN-01 as a promising treatment option that enhances existing therapies. Leap is poised to continue driving innovations that benefit patient care in oncology.
Frequently Asked Questions
What is the purpose of the DeFianCe study?
The DeFianCe study aims to evaluate the efficacy of DKN-01 combined with bevacizumab and chemotherapy as a treatment for advanced colorectal cancer patients who have received prior systemic therapy.
How many patients participated in the DeFianCe study?
A total of 188 patients were enrolled in Part B of the DeFianCe study, which is designed as a randomized controlled trial.
What are the primary objectives of Part B in the study?
The primary objectives focus on measuring progression-free survival rates and assessing the impact on specific subpopulations, particularly those with left-sided colorectal cancer.
What are the future plans for Leap Therapeutics?
Leap Therapeutics plans to share initial data from Part B of the study mid-next year and continues to focus on developing oncology therapeutics.
What distinguishes DKN-01 from other therapies?
DKN-01 is a unique therapeutic agent that targets the DKK1 protein, presenting potential for enhanced responses when combined with established treatment options in oncology.
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