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Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma

NCT03799744 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-03-28

No results posted yet for this study

Summary

This is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.

Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1.

The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.

Conditions

  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell of Head and Neck
  • Metastasis
  • Recurrence

Interventions

GENETIC

VCN-01

Dose level 1: 3.3x10\^12 viral particles/patient and Dose level 2: 1x10\^13 viral particles/patient

BIOLOGICAL

Durvalumab

Dose: 1500 mg Q4W

Sponsors & Collaborators

  • Theriva Biologics SL

    collaborator INDUSTRY

  • BioClever 2005 S.L.

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Institut Català d'Oncologia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03799744 on ClinicalTrials.gov