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

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

The study consists of three parts:

• Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
• In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
• In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.

Inclusion Criteria:

• Male/Female patients aged 18 years or over
• Patients must provide written informed consent
• Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
• Life expectancy above 3 months
• Patients willing to comply with treatment follow-up
• ECOG Performance status 0 or 1
• Adequate baseline organ function (hematologic, liver, renal and nutritional)
• Use a reliable method of contraception in fertile men and women

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