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Phase 2 Study of DKN-01 in Colorectal Cancer

Program Status

Completed

Phase

Phase 2

Prior Immunotherapy Allowed

CRC-directed Trial

Yes

Drugs

Bevacizumab, DKN-01, FOLFIRI, FOLFOX

Tags

MSS/ MMRp

Comments

Trial only for patients who are about to start second line of treatment for metastatic disease. Only for MSS, no BRAF mutation allowed. No prior checkpoint inhibitor allowed.
Randomized, one arm receives the standard of care (FOLFIRI or FOLFOX + bevacizumab), the experimental arm consists of DKN-01 + FOLFIRI or FOLFOX + bevacizumab.

DKN-01: humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein; enhances innate immune responses in the tumor microenvironment.

Helpful Links

Location	Location Status
United States
The University of Arizona Cancer Center Tucson, Arizona 85719	Completed
UCLA Los Angeles, California 90404	Completed
Florida Cancer Specialists & Research Institute (FCS) Cape Coral, Florida 33909	Completed
Florida Cancer Specialists & Research Institute Fleming Island, Florida 32003	Completed
Florida Cancer Specialists & Research Institute Gainesville, Florida 32605	Completed
Miami Cancer Institute Miami, Florida 33176	Completed
Florida Cancer Specialists & Research Institute Wellington, Florida 33414	Completed
Hematology Oncology Clinic Baton Rouge, Louisiana 70809	Completed
Center for Cancer and Blood Disorders Bethesda, Maryland 20817	Completed
Oncology Hematology Associates - Springfield Springfield, Missouri 65807	Completed
Northwell Health Lake Success, New York 11020	Completed
New York University New York, New York 10016	Completed
Cornell University New York, New York 10021	Completed
Mount Sinai Medical Center - New York New York, New York 10029	Completed
White Plains Hospital White Plains, New York 10601	Completed
Messino Cancer Centers Asheville, North Carolina 28806	Completed
Duke University Medical Center Durham, North Carolina 27710	Completed
Wake Forest University Winston-Salem, North Carolina 27157	Completed
Prisma Health Cancer Institute - Faris Greenville, South Carolina 29605	Completed
Sanford Cancer Center Sioux Falls, South Dakota 57104	Completed
Tennessee Oncology Chattanooga, Tennessee 37404	Completed
SCRI Oncology Partners Nashville, Tennessee 37203	Completed
Tennessee Oncology Nashville, Tennessee 37203	Completed
MultiCare Tacoma General Hospital Tacoma, Washington 98405	Completed
University of Wisconsin Hospital and Clinics Madison, Wisconsin 53792	Completed
Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Universitaeres Cancer Center Hamburg (UCCH) Hamburg	Completed
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT) Heidelberg	Completed
SLK-Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen - Klinik fuer Innere Medizin III Heilbronn	Completed
Gemeinschaftspraxis fuer Haematologie und Onkologie - Magdeburg Magdeburg	Completed
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz	Completed
Korea, Republic of
Dong-A University Medical Center Busan	Completed
Kyungpook National University Chilgok Hospital Daegu	Completed
Gachon University Gil Medical Center Incheon	Completed
Inha University Hospital Incheon	Completed
CHA University - Bundang CHA General Hospital Seongnam-si	Completed
Seoul National University Bundang Hospital Seongnam-si	Completed
Asan Medical Center Seoul	Completed
Samsung Medical Center Seoul	Completed
Seoul National University Hospital Seoul	Completed
The Catholic University of Korea - St. Vincent's Hospital Suwon	Completed

Inclusion Criteria

Adult patients with advanced CRC with measurable disease (RECIST v1.1) who have radiographically progressed during or following one line of systemic treatment will be enrolled in the study.

Inclusion Criteria:

Patients meeting all of the following criteria will be considered eligible for study entry:

1. Disease progression following first-line systemic therapy with any fluoropyrimidine-based regimen for advanced disease (except FOLFOXIRI, see

Exclusion Criteria

exclusion criteria).

• Patients may have received prior neoadjuvant or adjuvant therapy which could have included irinotecan or oxaliplatin. If progression has occurred within 12 months from last dose of neoadjuvant or adjuvant treatment, this regimen will be considered as the one line of systemic therapy for advanced disease.
* If assigned to receive FOLFIRI, patient may have received no prior irinotecan as part of first-line systemic therapy.
* If assigned to receive FOLFOX, patient may have received no prior oxaliplatin as part of first line systemic therapy.
* Prior treatment with an anti-VEGF or anti-EGFR therapy is allowed as first-line and/or maintenance systemic therapy.
2. Able to provide written informed consent for any study specific procedures.
3. One or more tumors measurable on radiographic imaging as defined by RECIST 1.1
4. Sufficient tumor tissue for mandatory pre-treatment evaluation (fresh biopsy [preferred], or archived tissue block specimen).
5. ECOG performance status ≤1 within 7 days of first dose of study drug. Acceptable liver, renal, hematologic, and coagulation function
6. Females of childbearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for study entry:

1. Diagnosis of Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAF V600E mutation positive colorectal cancer.
2. Prior therapy with an anti-DKK1, FOLFOXIRI, PD-1, anti-PD-L1, anti-PD-L-2 or any other antibody or drug specifically targeting T-cell co-stimulation or coinhibitory checkpoint.
3. Systemic anti-cancer therapy within 28 days prior to first dose of study drug.
4. Major surgery within 28 days prior to first dose of study drug.
5. Prior radiation therapy within 14 days prior to first dose of study drug.
6. Active leptomeningeal disease or uncontrolled brain metastases.
7. Any active cancer ≤ 2 years before first dose of study drug with the exception of cancer for this study.
8. New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, or unstable arrhythmia.
9. Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital long QT syndrome.
10. Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study entry requiring systemic therapy.
11. Serious nonmalignant disease
12. Pregnant or nursing.
13. History of osteonecrosis of the hip or have evidence of structural bone abnormalities in the proximal femur on MRI scan that are symptomatic and clinically significant.
14. Known osteoblastic bony metastasis.
15. Major surgery 28 days prior to study entry.
16. Prior radiation therapy within 14 days prior to study entry.
17. Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient.
18. Active substance abuse.
19. Known dihydropyrimidine dehydrogenase deficiency.
20. Administration of a live vaccine within 28 days before first dose of study drug

NCT ID

NCT05480306

Date Trial Added

2022-07-29

Updated Date

2025-08-03