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

Theriva Biologics

Status and phase: Completed; Phase 1

Conditions: Locally Advanced Solid Tumors; Pancreatic Adenocarcinoma; Metastatic Solid Tumors

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045602

2012-005555-16 (EudraCT Number)

P-VCNA-001

Details and patient eligibility

About

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.

Full description

The study consists of three parts:

• Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
• In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
• In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.

Enrollment: 42 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
• Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
• Life expectancy above 3 months
• Patients willing to comply with treatment follow-up
• 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
• 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
• Adequate levels of neutralizing antibodies against adenovirus
• Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Part I: Dose Escalation, Single Agent

Experimental group

Description:

Single intravenous injection of VCN-01 oncolytic adenovirus

Treatment:

Genetic: VCN-01

Part II: Dose Escalation, Combination

Experimental group

Description:

Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine

Treatment:

Drug: Abraxane®

Drug: Gemcitabine

Genetic: VCN-01

Part III: Dose Escalation, Combination, "delayed" schedule

Experimental group

Description:

Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine

Treatment:

Drug: Abraxane®

Drug: Gemcitabine

Genetic: VCN-01