Expanded Access Use of DKN-01 for the Treatment of Advanced Solid Tumors

NO_LONGER_AVAILABLE

Conditions studied: Esophageal Neoplasm, Adenocarcinoma of the Gastroesophageal Junction, GastroEsophageal Cancer, Squamous Cell Carcinoma, Gastric Adenocarcinoma, Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Carcinosarcoma, Gastric Cancer

In brief

An Expanded Access Protocol for use of DKN-01 for the treatment of advanced solid tumors.

Key facts

Study ID

NCT04681248

Run by

Leap Therapeutics, Inc.

Last updated by the study team

2025-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Cedars Sinai Medical Care Foundation — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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