On May 26, 2022 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that initial clinical data from the investigator-sponsored Phase 1b/2a dose escalation and dose expansion study testing Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer (mCRPC) will be presented at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, IL on June 3-7, 2022 (Press release, Leap Therapeutics, MAY 26, 2022, View Source [SID1234615146]).
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"As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study. "DKN-01, as a monotherapy and in combination with docetaxel, was well tolerated by patients, with partial responses in all of the patients treated with DKN-01 in combination with docetaxel who had measurable disease. Accrual into the Phase 2 portion of this study is ongoing, alongside preclinical and correlative studies aiming to further investigate the mechanism of action of DKN-01 in prostate cancer and to identify the best clinical path forward."
Key Initial Findings from the Investigator-Sponsored Phase 1b/2a Clinical Trial:
Data that will be presented at ASCO (Free ASCO Whitepaper) is from the completed Phase 1 portion of the study. Thirteen patients were enrolled, with 7 patients in the DKN-01 monotherapy cohort and 6 patients in the DKN-01 plus docetaxel combination cohort. The primary endpoint of the Phase 1 dose escalation cohorts was safety, characterized by dose-limiting toxicity (DLT). The study also aims to study correlations between DKK1 expression and tumor genetics, histology and anti-tumor activity.
Highlights from the data include:
No DLTs were observed at DKN-01 300mg or 600mg dose levels as monotherapy or in combination with docetaxel, and no treatment-related adverse events occurred in either cohort
No partial responses (PR) were seen in the monotherapy cohort with best overall response of stable disease in 2 out of 5 evaluable patients
In the combination cohort, all 5 evaluable patients had a PR as measured by RECIST (3 confirmed, 2 unconfirmed) and by PSA50
Confirmed partial responses in the combination cohort were observed in both DKK1 high and low expressing tumors, including in 2 out of 3 patients with aggressive variant prostate cancer (AVPC)
Further accrual into the phase 2 part of this study is ongoing, alongside preclinical and correlative studies aimed at investigating the mechanism of action of DKN-01 in prostate cancer.