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
HB-201 is an arenavirus vector-based vaccine expressing the inactivated fusion protein HPV 16 E7E6. This is a first in human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 monotherapy or in combination with an immune checkpoint inhibitor in HPV 16+ confirmed cancers that consists of 2 parts: Phase I Dose Escalation and Phase II Dose Expansion.
- HPV-Related Squamous Cell Carcinoma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
for both Dose escalation groups:
1. Male or female patients 18 years of age.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
3. Measurable disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
4. Documentation of histologically confirmed HPV 16+ cancer.
5. Tumor progression or recurrence on standard of care therapy, including at least 1 systemic therapy, or for patients for whom standard of care therapy is contraindicated.
Inclusion Criteria for Dose escalation Group 1 only (HPV 16+ head and squamous cell carcinoma )
1. Documentation of histologically confirmed HPV 16+ HNSCC.
2. Must have or provide tumor tissue (archival [no older than 2 years] or fresh biopsy specimen) collected following the patient's progression from the last treatment.
Inclusion Criteria for Dose escalation Group 2 only (HPV 16+ cancers with a safe and accessible tumor site)
1. Must have a safe and accessible tumor site amenable for biopsy and IT administration.
2. Must have at least 1 additional measurable lesion apart from the tumor site amenable for biopsy and IT administration
- Patients with untreated and/or symptomatic metastatic central nervous system (CNS) disease.
- Any serious or uncontrolled medical disorder that may increase the risk associated with study participation.
- Concurrent malignancy that is clinically significant or requires active intervention.
- Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
- Patients who have had a prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
Group 1- HPV 16+ head and neck squamous cell carcinoma
Group 2- HPV 16+ cancers with a safe and accessible tumor site
- Hookipa Biotech
Study ContactGeneral Hookipa contact
+43 1 890 6360
The Phase I Dose Escalation is a safety run-in to determine a safe recommended Phase II dose (RP2D) of HB-201 for intravenous (IV) and intratumoral (IT) treatment.
The Phase II Dose Expansion will commence after the RP2D has been defined in the Phase I Dose Escalation part. Further characterization of safety, tolerability, antitumor activity, and immunogenicity of HB-201 in a larger cohort at 1 dose level will be done during the Phase II Dose Expansion phase in 3 treatment groups.