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

Inclusion Criteria: * 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: 1. Total bilirubin ≤ 2.0 times upper limit of normal (ULN). Total bilirubin must be \< 3 X ULN for patients with Gilbert's syndrome. 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 X ULN (if liver metastases are present, then ≤ 5 X ULN is allowed). 3. Serum creatinine ≤ 1.5 X ULN. 4. Neutrophil absolute count ≥ 1,500/mm3 (≥1.5 X 109/L). 5. Platelet count ≥ 75,000/mm3 (≥100 X 109/L). 6. Hemoglobin ≥ 9g/dL (transfusion within 30 days of screening is permitted). Exclusion Criteria: * 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: 1. Pulmonary embolism within 28 days before first dose of study drug. 2. Any history of acute myocardial infarction within 6 months before first dose of study drug. 3. 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).