The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.
Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Genetically modified human adenovirus encoding human PH20 hyaluronidase
1000 mg/m2 intravenous administration
125 mg/m2 intravenous administration
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Centro Integral Oncológico Clara Campal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
Time frame: At least 6 months
Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
Time frame: At least 6 months
Presence of VCN-01 in tumor
Determination of VCN-01 viral genome copies in tumor biopsy
Time frame: Day 21-28
Viral Pharmacokinetics
Determination of VCN-01 half-life by analyzing viral genome copies in blood
Time frame: 48 h
Viral Shedding
At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
Time frame: Up to day 71
Neutralizing antibodies anti-VCN-01
At least up to 6 months follow-up in patients at the MTD
Time frame: 30 days after end of treatment phase
Preliminary anti-tumor activity by Overall Response Rate (ORR)
Time frame: CT or MRI scans every 8 weeks until disease progression
Preliminary anti-tumor activity by Progression Free Survival (PFS)
Time frame: CT or MRI scans every 8 weeks until disease progression
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