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

This is an expanded access trial for Esophageal Neoplasm focused on measuring DKK1, DKN-01, epithelial histology, Wnt pathway, endometrial, uterine, ovarian, carcinosarcoma, gastric cancer, gastroesophageal junction Read More

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).