drugset / Trial / NCT02045602

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

NCT02045602

Phase 1 Completed 42 enrolled Theriva Biologics SL
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2014-01
Primary completion
2019-05
Completion
2020-01

Drugs

EvaluationDrugModalityDoseRoute
Subject zabilugene almadenorepvec Unknown 3.3e+12 unknown Intravenous
Subject zabilugene almadenorepvec Unknown 1e+13 unknown Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous