Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor

Exclusion criteria

• . Known or suspected metastatic disease or other active, invasive malignancy.
• . Female patients of childbearing potential who are lactating or pregnant (negative serum pregnancy test needed prior to dosing).
• . Clinically active or uncontrolled skin disease or tattoos that would interfere with evaluation of the area surrounding the target tumour (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
• . Known history of sensitivity to any of the ingredients in ASN-002 and any Hh pathway inhibitors.
• . Immunocompromised (e.g. known Hepatitis B or C infection, HIV infection) or receiving or expected to receive an immunomodulating agent (including immunosuppressive agents, cytotoxic drugs, biological agents, immunoglobulins, interferon or other immune or cytokine-based therapies. Use of inhaled or oral corticosteroids at doses higher than physiological replacement doses is an exclusion criterion).
• . Has received or is expected to receive treatment with psoralen plus UVA or UVB therapy within 6 months of the Screening visit.
• . Any prior systemic anti-tumour therapy or local treatment for target tumours prior to first dose.
• . History of immunological disorder, severe allergic reaction, moderate or severe asthma or known history of anaphylaxis or any other serious adverse reactions to any medication.