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

Pancreatic Adenocarcinoma Clinical Trial

Official title:

A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045602
• Other study ID #: P-VCNA-001
• Secondary ID: 2012-005555-16
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: January 2020

Study information

• Verified date: October 2020
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2020
• Est. primary completion date: May 2019
• 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

• 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

Related Conditions & MeSH terms

• Locally Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms
• Pancreatic Adenocarcinoma

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	Hospital Vall d'Hebron	Barcelona
Spain	Institut Català d'Oncologia	Hospitalet De Llobregat
Spain	Centro Integral Oncológico Clara Campal	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	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) 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 by analyzing viral genome copies in tumor biopsy	Day 8-10
Secondary	Viral Pharmacokinetics	Determination of VCN-01 half-life by analyzing viral genome copies in blood	Up to 48 h
Secondary	Viral Shedding	And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)	Up to day 28
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