drugset / Trial / NCT04180215

A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers

NCT04180215

Phase 1/2 Completed 198 enrolled Hookipa Biotech GmbH
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 \& HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.

Timeline

Start
2019-12-11
Primary completion
2025-01-09
Completion
2025-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject HB-201 Vaccine Intravenous
Subject HB-202 Vaccine Intravenous
Subject Zr-Df-IAB22M2C Diagnostic / imaging agent
Background Pembrolizumab Monoclonal antibody