Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma, Squamous Cell of Head and Neck
- Head and Neck Neoplasms
- Metastasis
- Recurrence
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 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. The investigational treatment will be a single i.v. VCN-01 dose combined with concomitant i.v. durvalumab (MEDI4736) 1500 mg Q4W (Arm I) or durvalumab starting two weeks after VCN-01 administration, "sequential schedule" (Arm II). Patient recruitment in Arm I and Arm II will be performed in parallel based on slot availability. Only one single dose of VCN-01 will be administered to each patient during the trial. Durvalumab will be administered Q4W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 combin...
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.
Tracking Information
- NCT #
- NCT03799744
- Collaborators
- VCN Biosciences, S.L.
- BioClever 2005 S.L.
- AstraZeneca
- Investigators
- Not Provided
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