Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Active infection or other serious illness or autoimmune disease
• •Treatment with live attenuated vaccines in the last three weeks
• •Known chronic liver disease (liver cirrhosis, chronic hepatitis)
• •Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
• •Viral syndrome diagnosed during the two weeks before inclusion
• •Chronic immunosuppressive therapy
• •Concurrent malignant hematologic or solid disease
• •Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
• •Patients receiving full-dose anticoagulant / antiplatelet therapy
• •Adequate levels of neutralizing antibodies against adenovirus
• •Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency