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Completed Phase 2 Interventional

Phase 2 Study of DKN-01 in Colorectal Cancer

ClinicalTrials.gov ID: NCT05480306

Public ClinicalTrials.gov record NCT05480306. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Phase 2 Study of DKN-01 Plus FOLFIRI/FOLFOX and Bevacizumab Versus FOLFIRI/FOLFOX and Bevacizumab as Second-line Treatment of Advanced Colorectal Cancer (DeFianCe)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of care (SOC) \[FOLFIRI/FOLFOX and bevacizumab\] as second-line treatment of advanced CRC patients.

Study identification

NCT ID
NCT05480306
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Leap Therapeutics, Inc.
Industry
Enrollment
188 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 29, 2022
Primary completion
Jul 9, 2025
Completion
Jul 9, 2025
Last update posted
Aug 2, 2025

2022 – 2025

United States locations

U.S. sites
25
U.S. states
13
U.S. cities
22
Facility City State ZIP Site status
The University of Arizona Cancer Center Tucson Arizona 85719
UCLA Los Angeles California 90404
Florida Cancer Specialists & Research Institute (FCS) Cape Coral Florida 33909
Florida Cancer Specialists & Research Institute Fleming Island Florida 32003
Florida Cancer Specialists & Research Institute Gainesville Florida 32605
Miami Cancer Institute Miami Florida 33176
Florida Cancer Specialists & Research Institute Wellington Florida 33414
Hematology Oncology Clinic Baton Rouge Louisiana 70809
Center for Cancer and Blood Disorders Bethesda Maryland 20817
Oncology Hematology Associates - Springfield Springfield Missouri 65807
Northwell Health Lake Success New York 11020
New York University New York New York 10016
Cornell University New York New York 10021
Mount Sinai Medical Center - New York New York New York 10029
White Plains Hospital White Plains New York 10601
Messino Cancer Centers Asheville North Carolina 28806
Duke University Medical Center Durham North Carolina 27710
Wake Forest University Winston-Salem North Carolina 27157
Prisma Health Cancer Institute - Faris Greenville South Carolina 29605
Sanford Cancer Center Sioux Falls South Dakota 57104
Tennessee Oncology Chattanooga Tennessee 37404
SCRI Oncology Partners Nashville Tennessee 37203
Tennessee Oncology Nashville Tennessee 37203
MultiCare Tacoma General Hospital Tacoma Washington 98405
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05480306, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 2, 2025 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05480306 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →