US-based biotechnology firm Leap Therapeutics has entered an immunotherapy collaboration with Belgian European Organisation for the Research and Treatment of Cancer (EORTC) to conduct a clinical trial of DKN-01 to treat advanced biliary tract cancers.

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To be sponsored by EORTC, the trial will include a combination of DKN-01 with Roche’s atezolizumab (Tecentriq) with or without addition of paclitaxel.

Being developed as both a monotherapy and a combination therapy, DKN-01 is a humanised monoclonal antibody designed to target the Dickkopf-1 (DKK1) protein.

Set to commence enrolment next year at various EORTC centres in Europe, the trial will assess the efficacy and safety of the Wnt-targeted therapy and immune checkpoint inhibitor combination with and without chemotherapy.

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"We look forward to expanding our clinical studies into Europe with the support of the EORTC Gastrointestinal tract cancer Group (GITCG)."

Leap Therapeutics clinical development vice-president Cynthia Sirard said: “We look forward to expanding our clinical studies into Europe with the support of the EORTC Gastrointestinal tract cancer Group (GITCG).

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“This immunotherapy collaboration further expands our vision as we look to build upon the foundational activity we have seen with DKN-01 and backbone chemotherapy in these malignancies with significant unmet medical need.”

Reported to have shown single agent activity for treatment of non-small-cell lung cancer, DKN-01 is being further studied in an investigator-initiated trial to treat patients with hepatocellular carcinoma.

The firm is also evaluating its product candidate in combination with gemcitabine and cisplatin for biliary tract cancer, and alone as well as in combination with paclitaxel for esophagogastric cancer.

Image: CT of oesophageal cancer. Photo: courtesy of Tdvorak.