Tumour invasion into vein in a case of colorectal cancer. Credit: Patho / commons.wikimedia.org.

Leap Therapeutics has concluded enrolment in Part A of the Phase ll DeFianCe trial of its DKN-01 antibody along with standard of care bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer (CRC) patients.

The randomised, open-label, multicentre trial has included patients with advanced CRC who have already received a systemic therapy for advanced disease. 

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The trial’s initial Part A cohort included 33 patients. It plans to add 130 patients in its Part B randomised controlled portion.

Primary objective of the trial is progression free survival, while the secondary objectives are overall response rate, overall survival and duration of response.

Leap Therapeutics chief medical officer Cynthia Sirard said: “The completion of enrolment of Part A of the DeFianCe study is an important milestone for the DKN-01 colorectal cancer development programme.

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“We were very pleased with the enthusiasm of our investigators and patients for participating in Part A, which reflects the unmet medical need of second-line CRC patients and their conviction in the DKN-01 preclinical data and mechanism of action.

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“We look forward to initial data from the study in mid-2023.”

In October last year, Leap announced the enrolment of the first subject in the DeFianCe trial.

The company’s DKN-01 is a humanised monoclonal antibody that attaches to and blocks the Dickkopf-1 (DKK1) protein activity.

The antibody is also being assessed in the randomised controlled DisTinGuish trial along with tislelizumab and chemotherapy to treat first-line gastric cancer patients.