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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Locally Advanced Solid Tumors Metastatic Solid Tumors Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part I: Dose Escalation, Single Agent

Single intravenous injection of VCN-01 oncolytic adenovirus

Group Type EXPERIMENTAL

VCN-01

Intervention Type GENETIC

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Part II: Dose Escalation, Combination

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

Group Type EXPERIMENTAL

VCN-01

Intervention Type GENETIC

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Gemcitabine

Intervention Type DRUG

1000 mg/m2 intravenous administration

Abraxane®

Intervention Type DRUG

125 mg/m2 intravenous administration

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

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

Group Type EXPERIMENTAL

VCN-01

Intervention Type GENETIC

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Gemcitabine

Intervention Type DRUG

1000 mg/m2 intravenous administration

Abraxane®

Intervention Type DRUG

125 mg/m2 intravenous administration

Interventions

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VCN-01

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Intervention Type GENETIC

Gemcitabine

1000 mg/m2 intravenous administration

Intervention Type DRUG

Abraxane®

125 mg/m2 intravenous administration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No