Have you or your loved ones been diagnosed with locally advanced solid tumors?

You may be eligible to participate in a locally advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with locally advanced solid tumors? You may be eligible to participate in a locally advanced solid tumors clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Locally Advanced Solid Tumors Clinical Trial in Madrid

NCT02045602 | Phase 1 | Interventional

Have you or your loved ones been diagnosed with locally advanced solid tumors?

You may be eligible to participate in a locally advanced solid tumors clinical trial.

Have you or your loved ones been diagnosed with locally advanced solid tumors? You may be eligible to participate in a locally advanced solid tumors clinical trial.

Completed

Male & Female

18 Years +

This study has recruited 42 Participants

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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Details for the study

Brief Title

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

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

Brief Summary

The purpose of this study is to determine the safety and tolerability of VCN-01 either<br /> administered alone or in combination with Abraxane®/Gemcitabine, and to determine the<br /> recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.

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.

Treatments and/or Procedures

Gemcitabine

1000 mg/m2 intravenous administration

Abraxane

125 mg/m2 intravenous administration

VCN 01

Genetically modified human adenovirus encoding human PH20 hyaluronidase

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Presence of VCN-01 in tumor

Determination of VCN-01 by analyzing viral genome copies in tumor biopsy

Day 8-10

Study 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