Pancreatic Adenocarcinoma Clinical Trial
Official title:
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.
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