A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer

Pancreatic Adenocarcinoma Clinical Trial

Official title:

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045589
• Other study ID #: P-VCNA-002
• Secondary ID: 2012-005556-42
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: VCN Biosciences, S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male/Female patients aged 18 years or over

• Patients must provide written informed consent

• Life expectancy above 3 months

• Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment

• Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.

• ECOG Performance status 0 or 1

• Adequate baseline organ function (hematologic, liver, renal and nutritional)

• Use a reliable method of contraception in fertile men and women

Exclusion Criteria:

• Active infection or other serious illness or autoimmune disease

• Treatment with live attenuated vaccines in the last three weeks

• Known chronic liver disease (liver cirrhosis, chronic hepatitis)

• Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion

• Viral syndrome diagnosed during the two weeks before inclusion

• Chronic immunosuppressive therapy

• Known concurrent malignant hematologic or solid disease

• Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.

• Patients receiving full-dose anticoagulant / antiplatelet therapy

• Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Genetic:
• VCN-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase

Drug:
• Gemcitabine
1000 mg/m2 intravenous administration
• Abraxane®
125 mg/m2 intravenous administration

Locations

Country	Name	City	State
Spain	Institut Català d'Oncologia	L'Hospitalet De Llobregat	Barcelona
Spain	Centro Integral Oncológico Clara Campal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
VCN Biosciences, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability by means of Adverse Events (AEs) and laboratory data		At least 6 months
Primary	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		At least 6 months
Secondary	Presence of VCN-01 in tumor	Determination of VCN-01 viral genome copies in tumor biopsy	Day 21-28
Secondary	Viral Pharmacokinetics	Determination of VCN-01 half-life by analyzing viral genome copies in blood	48 h
Secondary	Viral Shedding	At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)	Up to day 71
Secondary	Neutralizing antibodies anti-VCN-01	At least up to 6 months follow-up in patients at the MTD	30 days after end of treatment phase
Secondary	Preliminary anti-tumor activity by Overall Response Rate (ORR)		CT or MRI scans every 8 weeks until disease progression
Secondary	Preliminary anti-tumor activity by Progression Free Survival (PFS)		CT or MRI scans every 8 weeks until disease progression