Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  1. Patients with untreated and/or symptomatic metastatic central nervous system (CNS) disease.
  2. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation.
  3. Concurrent malignancy that is clinically significant or requires active intervention.
  4. Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
  5. Patients who have had a prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1- HPV 16+ head and neck squamous cell carcinoma
  • Drug: HB-201 intravenous administration
    Dose level to be assigned based on 3+3 dose escalation (3 to 6 patients per cohort).
Experimental
Group 2- HPV 16+ cancers with a safe and accessible tumor site
  • Drug: HB-201 intratumoral administration on first cycle, followed by HB-201 intravenous administration on subsequent cycles
    HB-201 dose level to be assigned based on 3+3 dose escalation (3 to 6 patients per cohort).

Recruiting Locations

Montefiore-Einstein Center for Cancer Care
Bronx, New York 10461
Contact:
Sanjay Goel, MD

More Details

Status
Recruiting
Sponsor
Hookipa Biotech

Study Contact

General Hookipa contact
+43 1 890 6360
office@hookipabiotech.com

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.