NCT03799744

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Research Hypothesis The presence of VCN-01 into the tumor after systemic administration will help to overcome the observed resistance to durvalumab and other PD1/PD-L1 checkpoint inhibitors. * Primary objectives To evaluate the safety and tolerability of a single intravenous injection of VCN-01 combined with durvalumab in two administration regimens (concomitant or durvalumab starting two weeks later "sequential schedule"), and to determine the recommended phase II dose (RP2D) of the combination. * Study design This is a phase I trial, multicenter, open label, and dose escalation study. Patients will be entered at each dose level, according to a planned dose escalation schedule. Absence of unacceptable toxicity at the previous dose is required for entering a patient in the subsequent level. * Number of Centers: up to 3 * Number of Patients: 15-20 patients * Study Population: Patients with metastatic squamous cell carcinoma of the head and neck who have progressed during or after treatment with immune-checkpoint inhibitors.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-20
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2019-01-10
• Last updated: 2022-03-28

Locations

2 sites across 1 country: Spain