Leap Therapeutics completes enrollment of DKN-01 trial in gastric cancer

Leap Therapeutics announced that enrollment has been completed in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01, Leap’s anti-Dickkopf-1 antibody, in combination with tislelizumab, BeiGene’s anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer. Part C of the DisTinGuish study is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. Part C enrolled 170 first-line, HER2-negative patients. Patients were randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and standard of care chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is progression-free survival in DKK1-high and in all patients. Secondary objectives of Part C include overall survival and objective response rate as measured by RECIST v1.1 in DKK1-high and in all patients.