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

Sponsor
Institut Català d'Oncologia
Study ID
NCT03799744
Phase
PHASE1
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VCN-01 — GENETIC
    Dose level 1: 3.3x10\^12 viral particles/patient and Dose level 2: 1x10\^13 viral particles/patient
  • Durvalumab — BIOLOGICAL
    Dose: 1500 mg Q4W

Study Details

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.

Key Dates

Start date
Mar 20, 2019
Status verified
Mar 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: VCN-01 and Durvalumab; concomitant.
    Combination VCN-01 (single iv dose) with Durvalumab, Concomitant schedule; Dose Escalation of VCN-01
  • Experimental: VCN-01 and Durvalumab; sequential
    Combination VCN-01 (single iv dose) with Durvalumab, Delayed schedule (14 days); Dose Escalation of VCN-01

Primary Outcome Measure

Safety by means of Adverse Events (AEs) [ Time Frame: through study completion, an average of 2 years ]

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