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Clinical trialNCT05480306CompletedPhase 2Interventional

Phase 2 Study of DKN-01 in Colorectal Cancer

SponsorLeap Therapeutics, Inc.Enrollment188Colo-rectal CancerColorectal AdenocarcinomaColorectal CancerColorectal Cancer Metastatic
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

40 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany
  • Universitaetsklinikum Hamburg-Eppendorf (uke) - Universitaeres Cancer Center Hamburg (ucch)

    Hamburg, Germany

  • Universitaetsklinikum Heidelberg (ukhd) - Nationales Centrum Fuer Tumorerkrankungen Heidelberg (nct)

    Heidelberg, Germany

  • Slk-Kliniken Heilbronn Gmbh - Klinikum Am Gesundbrunnen - Klinik Fuer Innere Medizin Iii

    Heilbronn, Germany

  • Gemeinschaftspraxis Fuer Haematologie Und Onkologie - Magdeburg

    Magdeburg, Germany

  • Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz

    Mainz, Germany

South Korea
  • Dong-A University Medical Center

    Busan, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Inha University Hospital

    Incheon, South Korea

  • Cha University - Bundang Cha General Hospital

    Seongnam-si, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • the Catholic University of Korea - St. Vincent'S Hospital

    Suwon, South Korea

United States
  • the University of Arizona Cancer Center

    Tucson, Arizona, United States

  • Ucla

    Los Angeles, California, United States

  • Florida Cancer Specialists & Research Institute (fcs)

    Cape Coral, Florida, United States

  • Florida Cancer Specialists & Research Institute

    Fleming Island, Florida, United States

  • Florida Cancer Specialists & Research Institute

    Gainesville, Florida, United States

  • Miami Cancer Institute

    Miami, Florida, United States

  • Florida Cancer Specialists & Research Institute

    Wellington, Florida, United States

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana, United States

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, United States

  • Oncology Hematology Associates - Springfield

    Springfield, Missouri, United States

  • Northwell Health

    Lake Success, New York, United States

  • Cornell University

    New York, New York, United States

  • Mount Sinai Medical Center - New York

    New York, New York, United States

  • New York University

    New York, New York, United States

  • White Plains Hospital

    White Plains, New York, United States

  • Messino Cancer Centers

    Asheville, North Carolina, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Wake Forest University

    Winston-Salem, North Carolina, United States

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, United States

  • Sanford Cancer Center

    Sioux Falls, South Dakota, United States

  • Tennessee Oncology

    Chattanooga, Tennessee, United States

  • Scri Oncology Partners

    Nashville, Tennessee, United States

  • Tennessee Oncology

    Nashville, Tennessee, United States

  • Multicare Tacoma General Hospital

    Tacoma, Washington, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bevacizumab →DKN-01FOLFIRI Regimen →Folfox →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Aug 2022
Primary completion
10 Jul 2025
Completion
10 Jul 2025
Last update posted
3 Aug 2025
Registered enrollment
188
Registry id
NCT05480306
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.