The trial will assess DKN-01, along with tislelizumab and SOC chemotherapy, in patients with G/GEJ adenocarcinoma. Credit: Kwz / commons.wikimedia.org.

Leap Therapeutics has enrolled the first patient in Part C of the ongoing DisTinGuish Phase II clinical trial of its antibody DKN-01, along with tislelizumab, for gastric or gastroesophageal junction cancer (G/GEJ).

The randomised controlled trial will evaluate the anti-Dickkopf-1 (DKK1) antibody in combination with BeiGene’s anti-PD-1 antibody tislelizumab, and chemotherapy, versus a tislelizumab and chemotherapy control arm in these patients.

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It will assess DKN-01, along with tislelizumab and standard of care (SOC) chemotherapy, in patients with inoperable, locally advanced, G/GEJ adenocarcinoma.

Part C of this trial will enrol nearly 160 first-line, HER2-negative patients, who will be randomised into a 1:1 ratio for evaluating DKN-01 in combination with tislelizumab and SOC chemotherapy, against tislelizumab and SOC chemotherapy.

Progression-free survival (PFS) in DKK1-high patients is the primary objective of the trial.

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Part C’s secondary objectives include PFS in all subjects, irrespective of DKK1 expression, in addition to objective response rate and overall survival as measured by RECIST v1.1 in DKK1-high and all patients.

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Leap Therapeutics chief medical officer Cynthia Sirard said: “The data to date from the DisTinGuish study show the DKN-01 plus tislelizumab combination therapy to be a compelling potential treatment for patients with G/GEJ cancer, with response rates and survival outcomes that exceeded the benchmarks.

“This first randomised controlled study for DKN-01 will characterise the treatment effect in first-line patients, with a particular emphasis on those in the aggressive DKK1-high population.”

The humanised monoclonal antibody DKN-01 attaches to and blocks the Dickkopf-1 (DKK1) protein activity.

The antibody secured Orphan Drug Designation from the US Food and Drug Administration for the treatment of gastric and gastroesophageal junction cancer.