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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

NCT03837353 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-12-18

Study results available
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Summary

This is a non-randomized multi-center Phase 1b/2a dose escalation and dose expansion study 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.

Conditions

Interventions

DRUG

DKN-01

DKN-01 is a large molecular weight protein that will be given as a flat dose on a Days 1 and 15 of a 21-day cycle in Dose-Escalation Cohort 1A and Dose-Expansion Cohort 1B. DKN-01 will be given on Days 1 and 15 on a 28-day cycle in Dose-Escalation Cohort 2A and Dose-Expansion Cohort 2B. The dose of DKN-01 will be administered as an intravenous (IV) infusion over 60 (±) 15 minutes.

DRUG

Docetaxel

Docetaxel will be administered as an IV infusion over approximately 60 (±15) minutes on day 1 of a 21-day cycle in Cohorts 1A and 1B. In Cohort 1A, docetaxel must be dosed at 75 mg/m2 on cycle 1 day 1. Docetaxel can be dosed at 75 mg/m2 or 60 mg/m2 in subsequent cycles depending on clinical discretion and dose modification guidelines. Regardless of dose, docetaxel must be dosed in 21-day cycles. In Cohort 1B, cycle 1 day 1 dosing of docetaxel will either be 75 mg/m2 or 60 mg/m2 depending on clinical discretion.

Sponsors & Collaborators

Principal Investigators

  • David Wise, MD, PhD · New York Langone Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-07-19
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837353 on ClinicalTrials.gov