NCT02045602

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Theriva Biologics SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors
• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
GENETIC	VCN-01	Genetically modified human adenovirus encoding human PH20 hyaluronidase
DRUG	Gemcitabine	1000 mg/m2 intravenous administration
DRUG	Abraxane®	125 mg/m2 intravenous administration

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-05-01
• Completion: 2020-01-01
• First posted: 2014-01-27
• Last updated: 2020-10-08

Locations

5 sites across 1 country: Spain