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

Exclusion Criteria

• •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).
• •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.