NEW YORK – Leap Therapeutics said on Thursday that it has completed patient enrollment to the first part of its Phase II clinical trial evaluating its anti-Dickkopf-1 (DKK1) agent, DKN-01, combined with BeiGene's PD-L1 inhibitor tislelizumab, with and without chemotherapy for gastric or gastroesophageal junction (GEJ) cancer patients.
The trial, dubbed DisTinGuish, will be conducted in the US and Korea, and will enroll patients with inoperable, locally advanced gastric or GEJ adenocarcinoma. In the first part of the trial, within which enrollment was just completed, researchers will evaluate the treatment regimen as a first-line therapy in an estimated 24 treatment-naïve patients.
In the second part of the trial, researchers will evaluate just DKN-01 and tislelizumab, without the addition of chemotherapy, as a second-line treatment for roughly 48 patients who have received one prior therapy. To be eligible for this part of the study, patients' tumors must express elevated DKK1 mRNA, defined as an H-score of at least 35 based on immunohistochemistry testing.
The primary aim in the study is to assess DKN-01's safety and tolerability, and its secondary aims include evaluating objective response rates, duration of response, progression-free survival, and overall survival, among other endpoints, in both parts of the study.