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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

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•NYU Langone Health

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age \>18 years.
•Have a histologically or cytologically confirmed cancer of prostate origin (adenocarcinoma, poorly differentiated carcinoma, or neuroendocrine carcinoma are all allowed).
•* Patients with pure neuroendocrine carcinoma must have had at least one line of platinum-based chemotherapy unless the patient is intolerant of or is refusing chemotherapy.
•* Patients with pure neuroendocrine carcinoma do not need to have been previously treated with androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide or apalutamide or darolutamide) but must have castrate testosterone and have castration-resistant disease.
•Surgically or medically castrated, with testosterone levels of \< 50 ng/dL (\< 2.0 nM). If the patient is being treated with luteinizing hormone-releasing hormone (LHRH) agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to C1D1 and must be continued throughout the study.
•Cohorts 1A, 1B: Patients must have progressed despite 1 or more androgen receptor (AR) signaling inhibitors (abiraterone or enzalutamide or apalutamide or darolutamide) and have not received prior taxane-based chemotherapy for prostate cancer. Prior treatment with an AR signaling inhibitor for castration-sensitive disease will be allowed if the time to progression was within 1 year after starting drug. Prior treatment with a taxane-based chemotherapy for castration-sensitive disease will be exclusionary. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
•Cohorts 2A and 2B: Patients must have progressed despite 1 or more AR signaling inhibitor (abiraterone or enzalutamide or apalutamide or darolutamide) and either had disease progression, were intolerant of, or refused 1 or more taxane-based chemotherapies for mCRPC. (Prior treatment with an AR signaling inhibitor is not required for pure prostate neuroendocrine carcinoma as in inclusion 2.)
•Cohort 1B. Patients must have measurable disease per RECIST v1.1 guidelines AND must have either:
•* PSA progression is defined by Prostate Cancer Working Group 3 (PCWG3) criteria as a minimum of two consecutive rising levels, with an interval of ≥1 week between each determination with a minimum PSA of 1 ng/mL, if PSA is the sole evidence of progression, OR
•* Radionuclide bone progression as defined by at least two new metastatic lesions (per PCWG3), OR
+20 more criteria

Exclusion Criteria

•Any anti-cancer therapy (with the exception of luteinizing hormone-releasing hormone \[LHRH\] analog or antagonist) within 2 weeks prior to initiation of study treatment.
•Any investigational anti-cancer therapy within 4 weeks of initiation of study treatment.
•New York Heart Association Class III or IV heart failure, or myocardial infarction within the past 6 months, or unstable arrhythmia within 3 months.
•Uncontrolled bacterial, viral, or fungal infections, within 7 days of study entry.
•History of malignancy other than prostate cancer within 2 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as non-melanoma skin carcinoma or ductal carcinoma in situ.
•Known to be human immunodeficiency virus (HIV) positive, have positive hepatitis B surface antigen (HBSAg), or positive hepatitis C antibody (HCAb) test. (Hepatitis C antibody-positive patients with an undetectable hepatitis C virus (HCV) RNA will be eligible.)
•History of solid organ transplant (ie, heart, lungs, liver, or kidney).
•History of autologous/allogenic bone marrow transplant.
•Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator and/or Sponsor.
•Major surgical procedures or significant traumatic injury within 4 weeks prior to study entry (minor surgical procedures within 1 week of study entry). Note: Diagnostic cystoscopy is not exclusionary at any time during screening. History of osteonecrosis of the hip. Other hip pathology such as degenerative disease or malignant involvement are not exclusionary. Screening of asymptomatic patients is not required.
+13 more criteria

Locations (5)

University of California, San Francisco

San Francisco, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

Veterans Affairs New York Harbor Healthcare System

New York, New York, United States

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

April 1, 2019

Primary Completion Date

July 19, 2022

Completion Date

September 20, 2022

Last Updated

December 18, 2023

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

DKN-01

DRUG

Docetaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC