A Phase 1 interventional study of VCN-01 and Gemcitabine in Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, sponsored by Theriva Biologics SL. Completed at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-01.
Sponsored by Theriva Biologics SL · Phase 1, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 8 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Theriva Biologics SL is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.
Genetic: VCN-01 · Drug: Gemcitabine · Drug: Abraxane®
Genetically modified human adenovirus encoding human PH20 hyaluronidase
1000 mg/m2 intravenous administration
125 mg/m2 intravenous administration
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
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Theriva Biologics SL