Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2022-08-30
2025-07-10
Brief Summary
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Detailed Description
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In Parts A and B, approximately 200 evaluable adult advanced CRC patients with measurable disease (RECIST v1.1) who have radiographically progressed during or following 1 line of systemic treatment will be enrolled in the study.
The study consists of a Screening Period, a Treatment Period, a Safety Follow-up Period (SFUP) and a Long-Term Follow-up Period (LTFU). Patients will be followed in the SFUP for approximately 30 days (+7 days) after the last administration of study drug and then enter the LTFU period to be followed for survival and subsequent therapies. Additionally, patients that ended study treatment for a reason unrelated to progressive disease \[PD\] will also be followed for disease progression in the LTFU period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
DKN-01 + FOLFIRI or FOLFOX + bevacizumab
DKN-01
30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment
FOLFIRI
90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Bevacizumab
90-min IV infusion (5mg)
FOLFOX
2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Control
FOLFIRI or FOLFOX + bevacizumab
FOLFIRI
90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Bevacizumab
90-min IV infusion (5mg)
FOLFOX
2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Interventions
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DKN-01
30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment
FOLFIRI
90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Bevacizumab
90-min IV infusion (5mg)
FOLFOX
2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Leap Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Sirard
Role: STUDY_DIRECTOR
Leap Therapeutics, Inc.
Locations
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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
New York University
New York, New York, United States
Cornell University
New York, New York, United States
Mount Sinai Medical Center - New York
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
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
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
Countries
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Other Identifiers
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DEK-DKK1-P207
Identifier Type: -
Identifier Source: org_study_id
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