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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045602
Recruitment Status : Completed
First Posted : January 27, 2014
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Theriva Biologics SL

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumors Metastatic Solid Tumors Pancreatic Adenocarcinoma Genetic: VCN-01 Drug: Gemcitabine Drug: Abraxane® Phase 1

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2014
Actual Primary Completion Date : May 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part I: Dose Escalation, Single Agent
Single intravenous injection of VCN-01 oncolytic adenovirus
 Genetic: VCN-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase
Experimental: Part II: Dose Escalation, Combination
Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine
 Genetic: VCN-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase

Drug: Gemcitabine
1000 mg/m2 intravenous administration

Drug: Abraxane®
125 mg/m2 intravenous administration
Experimental: Part III: Dose Escalation, Combination, "delayed" schedule
Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine
 Genetic: VCN-01
Genetically modified human adenovirus encoding human PH20 hyaluronidase

Drug: Gemcitabine
1000 mg/m2 intravenous administration

Drug: Abraxane®
125 mg/m2 intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability by means of Adverse Events (AEs) and laboratory data [ Time Frame: At least 6 months ]
  2. Recommended Phase 2 Dose (RP2D) by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities [ Time Frame: At least 6 months ]

Secondary Outcome Measures :
  1. Presence of VCN-01 in tumor [ Time Frame: Day 8-10 ]
    Determination of VCN-01 by analyzing viral genome copies in tumor biopsy

  2. Viral Pharmacokinetics [ Time Frame: Up to 48 h ]
    Determination of VCN-01 half-life by analyzing viral genome copies in blood

  3. Viral Shedding [ Time Frame: Up to day 28 ]
    And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)

  4. Neutralizing antibodies anti-VCN-01 [ Time Frame: 30 days after end of treatment phase ]
    At least up to 6 months follow-up in patients at the MTD

  5. Preliminary anti-tumor activity by Overall Response Rate (ORR) [ Time Frame: CT or MRI scans every 8 weeks until disease progression ]
  6. Preliminary anti-tumor activity by Progression Free Survival (PFS) [ Time Frame: CT or MRI scans every 8 weeks until disease progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045602


Locations
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Spain
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Institut Català d'Oncologia
Hospitalet De Llobregat, Spain, 08908
Centro Integral Oncológico Clara Campal
Madrid, Spain, 25080
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Theriva Biologics SL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Theriva Biologics SL
ClinicalTrials.gov Identifier: NCT02045602    
Other Study ID Numbers: P-VCNA-001
2012-005555-16 ( EudraCT Number )
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Theriva Biologics SL:
Cancer
Solid Tumors
Gemcitabine
 Oncolytic virus
Metastatic
Pancreatic cancer
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Albumin-Bound Paclitaxel
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents