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Monoclonal Antibodies

Cohort 2B for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By David Wise, MD, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 2 post-baseline

Awards & highlights

Study Summary

This trial is testing DKN-01 as monotherapy or in combination with docetaxel to treat metastatic castration-resistant prostate cancer. Patients need to be biomarker positive for the trial.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 2 post-baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 2 post-baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 2 post-baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1

Number of Participants With a Best Overall Response of Complete Response (iCR) or Partial Response (iPR) Per iRECIST by End of Long-Term Follow-Up Period

Secondary outcome measures

Maximal Percent Change in PSA Measured After Treatment Initiation

Number of Participants With a Decline in Prostate-Specific Antigen (PSA) of at Least 50% Relative to Baseline

Progression-Free Survival (PFS)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2BExperimental Treatment1 Intervention

In dose-expansion Cohort 2B, the MTD or highest dose tested of DKN-01 monotherapy in Cohort 2A will be the dose used. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity.

Group II: Cohort 2AExperimental Treatment1 Intervention

In dose-escalation Cohort 2A, DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered as monotherapy on Days 1 and 15 of each 28-day cycle. Patients will be treated with DKN-01 until PCWG3 progression or unacceptable toxicity.

Group III: Cohort 1BExperimental Treatment2 Interventions

In dose-expansion Cohort 1B, either the maximum tolerated dose (MTD) or highest dose tested of DKN-01 in combination with docetaxel in Cohort 1A will be the dose used. The dose of docetaxel 75 mg/m2 will remain fixed. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until PCWG3 progression or unacceptable toxicity.

Group IV: Cohort 1AExperimental Treatment2 Interventions

In dose-escalation Cohort 1A, the dose of docetaxel 75 mg/m2 will remain fixed. The DKN-01 dose level will start with 300 mg and be escalated to 600 mg or de-escalated to 150 mg depending on the absence or presence of identified DLTs. DKN-01 will be administered in combination with docetaxel on Day 1 and as monotherapy on Day 15 of each 21-day cycle. Patients will be treated with the combination of DKN-01 and Docetaxel until Prostate Cancer Working Group 3 (PCWG3) progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~5620

DKN-01

2015

Completed Phase 1

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Leap Therapeutics, Inc.Industry Sponsor

15 Previous Clinical Trials

1,009 Total Patients Enrolled

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,743 Total Patients Enrolled

24 Trials studying Prostate Cancer

5,221 Patients Enrolled for Prostate Cancer

David Wise, MD, PhDPrincipal InvestigatorNew York Langone Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project exclude people over a certain age?

"The age requirements for this particular clinical trial are that patients must be aged 18-100. There are 1689 ongoing trials for those over 65 and 93 for those under 18."

Answered by AI

Which type of patient is most likely to see benefits from enrolling in this clinical trial?

"This clinical trial is only admitting 18 participants who must fit the following criteria: they should have prostate cancer and be between 18 to 100 years old."

Answered by AI

Could you please list the hospitals in this city that are running this clinical trial?

"Patients can enroll in this study at University of California, San Francisco; Veterans Affairs New york Harbor Healthcare System; NYU Langone Health; as well as 5 other centres across the country."

Answered by AI

Are there similar drugs to DKN-01 300 mg that have undergone clinical trials?

"There are 337 medical studies currently underway that focus on DKN-01 300 mg. Out of these, 132 are in Phase 3. Additionally, there are over 23,000 locations where clinical trials for DKN-01 300 mg are taking place with a majority based in Fuzhou, Fujian."

Answered by AI

Are researchers actively working to bring new participants into this trial?

"This particular study is no longer recruiting participants. The trial was posted on April 1st, 2019 and edited for the last time on July 11th, 2022. Currently, there are 1366 trials actively searching for participants with prostate cancer and 337 trials for DKN-01 300 mg that need patients."

Answered by AI

What is DKN-01 300 mg used to treat?

"DKN-01 300mg is most frequently used to treat patients with malignant neoplasms. This medication can also be helpful for those suffering from sarcoma, esophageal neoplasms, and other advance directives."

Answered by AI

How many subjects are taking part in this research?

"This particular clinical trial is no longer seeking out patients. The study was initially posted on April 1st, 2019 and updated for the last time on July 11th, 2022. However, there are presently 1366 other trials actively recruiting patients with prostate cancer and 337 studies for DKN-01 300 mg that have open enrollment."

Answered by AI

Recent research and studies

JCO Precision OncologyJournal

Dickkopf-1 Can Lead to Immune Evasion in Metastatic Castration-resistant Prostate Cancer

Wise, David R., Jeffrey A. Schneider, Joshua Armenia, Victor Adorno Febles, Bridget McLaughlin, Ryan Brennan, Katie L. Thoren, et al.. 2020. “Dickkopf-1 Can Lead to Immune Evasion in Metastatic Castration-resistant Prostate Cancer”. JCO Precision Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/po.20.00097.

clinicaltrials.govStudy

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

2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03837353.