Overview

A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1

Status:
Recruiting

Trial end date:
2021-03-01

Target enrollment:

Participant gender:

Summary

This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study involving 85-97 patients testing DKN-01 as monotherapy or in combination with docetaxel in metastatic castration-resistant prostate cancer. Patients need to be biomarker positive (Dickkopf-1 [DKK1]) either in plasma or biopsy. Other biopsies for correlative studies are encouraged but not mandatory. Pharmacokinetic (PK) testing of one pre-treatment blood sample and one post-treatment blood sample will be mandatory on Day 1 of every cycle.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

New York University School of Medicine
NYU Langone Health

Collaborator:

Leap Therapeutics, Inc.

Treatments:

Docetaxel