Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors
1 other identifier
expanded_access
N/A
1 country
5
Brief Summary
An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 23, 2020
CompletedAugust 3, 2025
July 1, 2025
December 18, 2020
July 30, 2025
Conditions
Keywords
Interventions
Administered by IV infusion
Eligibility Criteria
You may qualify if:
- Cytologically or histologically confirmed advanced solid tumors that are inoperable, locally advanced, metastatic, or recurrent, with no standard of care treatment options, and not eligible for enrollment to a DKN-01 clinical study, may be treated with DKN-01 in this study if in the opinion of the treating oncologist, would potentially receive benefit from treatment with DKN-01 while it is an investigational drug
- Prior documentation of a known Wnt activating mutation by a CLIA-accredited laboratory. Wnt activating mutations: CTNNB1, APC, AXIN1/2, RNF43, ZNRD3, RSPO2, RSPO3
- ECOG performance status (PS) of ≤ 2 (Medical Monitor's approval is needed for enrolling a patient with PS of 2).
- Laboratory values:
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN). Total bilirubin must be \< 3 X ULN for patients with Gilbert's syndrome.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN (if liver metastases are present, then ≤ 5 X ULN is allowed).
- Serum creatinine ≤ 1.5 X ULN.
- Neutrophil absolute count ≥ 1,500/mm3 (≥1.5 X 109/L).
- Platelet count ≥ 75,000/mm3 (≥100 X 109/L).
- Hemoglobin ≥ 9g/dL (transfusion within 30 days of screening is permitted).
You may not qualify if:
- Major surgery within 4 weeks of first dose of study drug.
- Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities).
- Any of the following cardiovascular risk factors:
- Pulmonary embolism within 28 days before first dose of study drug.
- Any history of acute myocardial infarction within 6 months before first dose of study drug.
- Uncontrolled hypertension that cannot be managed by standard anti-hypertension medications within 28 days before first dose of study drug.
- Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection within 14 days of first dose of study drug.
- Active brain metastases. Patients are eligible if brain metastases are adequately treated, and patients are neurologically stable for at least 2 weeks prior to enrolment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10mg daily prednisone (or equivalent).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Alabama
Birmingham, Alabama, 35294, United States
Cedars Sinai Medical Care Foundation
Los Angeles, California, 90025, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Wisconsin
Madison, Wisconsin, 53715, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2020
First Posted
December 23, 2020
Last Updated
August 3, 2025
Record last verified: 2025-07