ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02045602
Recruitment Status : Recruiting
First Posted : January 27, 2014
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
VCN Biosciences, S.L.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Teresa Macarulla, MD    +34 93 274 60 00 ext 4846    tmacarulla@vhio.net   
Principal Investigator: Teresa Macarulla, MD         
Institut Català d'Oncologia Recruiting
Hospitalet De Llobregat, Spain, 08908
Contact: Ramon Salazar, MD       ramonsalazar@iconcologia.net   
Principal Investigator: Ramon Salazar, MD         
Centro Integral Oncológico Clara Campal Recruiting
Madrid, Spain, 25080
Contact: Rafael Alvarez Gallego, MD       ralvarezgallego@hmhospitales.com   
Principal Investigator: Rafael Alvarez Gallego, MD         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Carmen Guillén, MD       carmenguillenponce@gmail.com   
Principal Investigator: Carmen Guillén, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Rocío García Carbonero, MD       rgcarbonero@gmail.com   
Principal Investigator: Rocío García Carbonero, MD         
Sponsors and Collaborators
VCN Biosciences, S.L.

Responsible Party: VCN Biosciences, S.L.
ClinicalTrials.gov Identifier: NCT02045602     History of Changes
Other Study ID Numbers: P-VCNA-001
2012-005555-16 ( EudraCT Number )
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

Keywords provided by VCN Biosciences, S.L.:
Cancer
Solid Tumors
Gemcitabine
Oncolytic virus
Metastatic
Pancreatic cancer

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gemcitabine
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators