This section highlights FDA-related milestones and regulatory updates for drugs developed by Leap Therapeutics (LPTX).
Over the past two years, Leap Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DKN-01 and FL-501. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DKN-01 - FDA Regulatory Timeline and Events
DKN-01 is a drug developed by Leap Therapeutics for the following indication: Advanced gynecological malignancies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DKN-01
- Announced Date:
- June 23, 2025
- Indication:
- Advanced gynecological malignancies
Announcement
Leap Therapeutics, Inc. today reported updated results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.
AI Summary
Leap Therapeutics, Inc. announced updated results from Part B of the DeFianCe study (NCT05480306), a Phase 2 trial evaluating sirexatamab (DKN-01) combined with bevacizumab and chemotherapy in patients with advanced microsatellite stable colorectal cancer who previously received one systemic therapy. In this study, the combination showed improved progression-free survival (PFS) compared to bevacizumab and chemotherapy alone. The positive results were especially evident in patients with high levels of DKK1, those who had not received prior anti-VEGF therapy, and patients with liver metastases. These findings suggest that sirexatamab may offer additional benefits in targeted groups of patients. The additional follow-up data support the study’s objectives and provide important insights for developing future treatment strategies for advanced colorectal cancer.
Read Announcement- Drug:
- DKN-01
- Announced Date:
- March 26, 2025
- Indication:
- Advanced gynecological malignancies
Announcement
Leap Therapeutics, Inc presented updated preliminary data on Wednesday from Part B of the DeFianCe Phase 2 trial of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm).
AI Summary
Leap Therapeutics, Inc. recently shared updated preliminary results from Part B of its DeFianCe Phase 2 trial. This study investigated the combination of sirexatamab (DKN-01) with bevacizumab and chemotherapy (the Experimental Arm) versus bevacizumab with chemotherapy alone (the Control Arm) in advanced microsatellite stable colorectal cancer patients who previously received one systemic therapy.
The data show that among patients with high DKK1 levels, those treated with sirexatamab experienced a 32% higher overall response rate and 3.5 months longer progression-free survival compared to the Control Arm. In patients without prior anti-VEGF therapy, the experimental treatment achieved a 22% higher overall response rate and extended progression-free survival by 2.6 months. The continued treatment in more patients from the Experimental Arm indicates promising potential for further strengthening of the data.
Read Announcement- Drug:
- DKN-01
- Announced Date:
- January 28, 2025
- Indication:
- Advanced gynecological malignancies
Announcement
Leap Therapeutics, Inc announced positive initial data from Part B of the DeFianCe study evaluating sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC), and initial data from Part C of the DisTinGuish study evaluating sirexatamab in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer.
AI Summary
Leap Therapeutics announced positive early results from its clinical studies. In the DeFianCe study, Part B focused on advanced colorectal cancer patients receiving sirexatamab with bevacizumab and chemotherapy as a second-line treatment. The combination showed a notable improvement in objective response rate compared to the control group. The impressive results, including higher response rates in patients with elevated DKK1 levels, support the company’s decision to plan for a Phase 3 registrational study in this population.
In the DisTinGuish study, Part C evaluated sirexatamab combined with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction and gastric cancer. While the data indicated activity in certain biomarker-defined groups, it did not achieve a strong enough signal for proceeding to Phase 3 trials in this indication.
Read Announcement- Drug:
- DKN-01
- Announced Date:
- September 30, 2024
- Indication:
- Advanced gynecological malignancies
Announcement
Leap Therapeutics, Inc. announced that enrollment of 188 patients has been completed in the randomized controlled Part B of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC).
AI Summary
Leap Therapeutics, Inc. announced that enrollment is now complete for Part B of its DeFianCe study, with 188 patients enrolled in this phase. The study is examining DKN-01, Leap’s anti-Dickkopf-1 antibody, in combination with standard bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer. This randomized controlled trial has expanded enrollment from the original 130 patients, allowing researchers to better assess progression free survival in the overall study group as well as in a specific subgroup of patients with left-sided colorectal cancer. Encouraging results from Part A, which showed significant tumor reductions and a good safety profile, have supported this expansion. Leap Therapeutics plans to reveal the initial data from Part B, including detailed results for patients with left-sided CRC, by mid-2025.
Read Announcement
FL-501 - FDA Regulatory Timeline and Events
FL-501 is a drug developed by Leap Therapeutics for the following indication: Novel GDF-15 Neutralizing Antibody.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FL-501
- Announced Date:
- April 25, 2025
- Indication:
- Novel GDF-15 Neutralizing Antibody
Announcement
Leap Therapeutics, Inc. announced it will present preclinical data of FL-501 in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois.
AI Summary
Leap Therapeutics, Inc. recently announced that it will present preclinical data for FL-501 at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, from April 25-30. The poster presentation will showcase FL-501, a potential best-in-class monoclonal antibody designed to target growth differentiation factor 15 (GDF-15). In preclinical studies, FL-501 has demonstrated the ability to fully restore body composition and reverse key signs of cachexia, a severe wasting condition commonly seen in cancer patients.
The data suggest that FL-501 offers improvements in half-life and clearance compared to other similar therapies, supporting its continued advancement toward clinical trials, potentially starting in 2026. The poster, presented by Dr. Roma Kaul, will be part of the Experimental and Molecular Therapeutics session at AACR, highlighting FL-501’s promising role in addressing cancer-related cachexia.
Read Announcement
