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 treatmentoptions, and not eligible for enrollment to a DKN-01 clinical study, may be treatedwith DKN-01 in this study if in the opinion of the treating oncologist, wouldpotentially receive benefit from treatment with DKN-01 while it is aninvestigational drug

• Prior documentation of a known Wnt activating mutation by a CLIA-accreditedlaboratory. Wnt activating mutations: CTNNB1, APC, AXIN1/2, RNF43, ZNRD3, RSPO2,RSPO3

• ECOG performance status (PS) of ≤ 2 (Medical Monitor's approval is needed forenrolling a patient with PS of 2).

• Laboratory values:

1. Total bilirubin ≤ 2.0 times upper limit of normal (ULN). Total bilirubin mustbe < 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 tobaseline 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 ofstudy drug.

3. Uncontrolled hypertension that cannot be managed by standard anti-hypertensionmedications within 28 days before first dose of study drug.

• Severe chronic or active infections requiring systemic antibacterial, antifungal orantiviral therapy, including tuberculosis infection within 14 days of first dose ofstudy drug.

• Active brain metastases. Patients are eligible if brain metastases are adequatelytreated, and patients are neurologically stable for at least 2 weeks prior toenrolment without the use of corticosteroids or are on a stable or decreasing doseof ≤ 10mg daily prednisone (or equivalent).