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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

NCT02045602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Theriva Biologics SL

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2019-05-31
Completion
2020-01-31

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02045602 on ClinicalTrials.gov