NCT04180215

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

A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients With HPV 16+ Confirmed Cancers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Hookipa Biotech GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people. The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.

Conditions

• HPV-Related Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	HB-201 intravenous administration.	Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
DRUG	HB-202 intravenous administration alternating with HB-201 intravenous administration.	Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
DRUG	HB-201 intravenous administration + standard of care regimen including pembrolizumab.	Dose Expansion
DRUG	HB-202 / HB-201 alternating intravenous administration + pembrolizumab.	Dose Expansion
DRUG	HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab.	Dose Expansion
DRUG	HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)	Dose escalation; 10 patients

Timeline

• Start date: 2019-12-11
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2019-11-27
• Last updated: 2025-09-15

Locations

34 sites across 3 countries: United States, Netherlands, Spain

Regulatory

• FDA-regulated drug study