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

Theriva Biologics

Status and phase: Completed; Phase 1

Conditions: Metastatic Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma

Treatments: Drug: Abraxane®; Genetic: VCN-01; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045589

2012-005556-42 (EudraCT Number)

P-VCNA-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Dose Escalation, Combination

Experimental group

Description:

Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine.

Treatment:

Drug: Gemcitabine

Drug: Abraxane®

Genetic: VCN-01