15 January 2019 - - US-based biotechnology company Leap Therapeutics, Inc. (NASDAQ: LPTX) has launched an investigator-initiated study led by David R. Wise, M.D., Ph.D. of the Perlmutter Cancer Center at NYU Langone Health to study DKN-01, as a monotherapy and in combination with docetaxel in patients with advanced prostate cancer, the company said.

This clinical trial is specifically targeting a biomarker-selected patient population in metastatic castration-resistant prostate cancer (mCRPC) with elevated Dickkopf-1 (DKK1) levels.

The study is expected to begin enrolling patients in the first quarter of 2019. mCRPC patients who have progressed on one or more androgen receptor therapies (Xtandi or Zytiga) will be screened for DKK1 elevation in their plasma or in a tumor sample.

Up to 97 patients will be enrolled in a dose-escalation and then dose expansion cohorts. DKK1+ mCRPC patients who have not received prior taxane chemotherapies will be treated with DKN-01 and docetaxel. DKN-01 will be given as a monotherapy to DKK1+ mCRPC patients who have progressed on or refused docetaxel treatment.

Prostate cancer is the leading type of non-skin cancer in the US, and the second leading cause of cancer worldwide. Approximately 1 in 9 men will be diagnosed with prostate cancer at some point in their lives. Androgen receptor -targeted therapy can be highly effective for the treatment of prostate cancer.

Unfortunately, most patients will eventually develop resistance and progress to castration-resistant prostate cancer, an incurable form of the disease.

Dr. Wise is compensated to serve as a consulant to Leap Therapeutics. Also, Dr. Wise's involvement in this upcoming study does not constitute an institutional endorsement from NYU Langone Health or its Perlmutter Cancer Center of the drug DKN-01 being studied.

Leap Therapeutics (NASDAQ: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanised monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator.

DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap's second clinical candidate, TRX518, is a humanised GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in advanced solid tumor studies.