Clinical Trials /

A Study of HB-201 Alone or in Combination With a Checkpoint Inhibitor in Patients With Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers'

NCT04180215

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of HB-201 Alone or in Combination With a Checkpoint Inhibitor in Patients With Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers'
  • Official Title: A Phase I/II Study of HB-201 Monotherapy or in Combination With Checkpoint Inhibitors in Patients With Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers'

Clinical Trial IDs

  • ORG STUDY ID: H-200-001
  • SECONDARY ID: 2019-000907-34
  • NCT ID: NCT04180215

Conditions

  • HPV-Related Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
HB-201 intravenous administrationGroup 1- HPV 16+ head and neck squamous cell carcinoma
HB-201 intratumoral administration on first cycle, followed by HB-201 intravenous administration on subsequent cyclesGroup 2- HPV 16+ cancers with a safe and accessible tumor site

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Group 1- HPV 16+ head and neck squamous cell carcinomaExperimental
  • HB-201 intravenous administration
Group 2- HPV 16+ cancers with a safe and accessible tumor siteExperimental
  • HB-201 intratumoral administration on first cycle, followed by HB-201 intravenous administration on subsequent cycles

Eligibility Criteria

        Inclusion Criteria:

          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.

          6. Documentation of histologically confirmed HPV 16+ HNSCC.

          7. 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.

          8. Must have a safe and accessible tumor site amenable for biopsy and IT administration.

          9. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recommended Phase 2 Dose (RP2D) for IV administration
Time Frame:1 year
Safety Issue:
Description:To determine the RP2D for IV administration of HB-201 in terms of safety and tolerability in patients with HPV 16+ confirmed advanced, recurrent, or metastatic HNSCC

Secondary Outcome Measures

Measure:Number of patients receiving IV HB-201 experiencing treatment-emergent adverse events.
Time Frame:1 year
Safety Issue:
Description:Adverse events that first occurred or worsened in severity after the first administration of study drug and prior to 30 days after the last administration of study treatment will be included.
Measure:Number of patients receiving IT HB-201 experiencing treatment-emergent adverse events
Time Frame:1 year
Safety Issue:
Description:Adverse Events that first occurred or worsened in severity after the first administration of study drug and prior to 30 days after the last administration of study treatment will be included.
Measure:Number of patients receiving IV HB-201 with tumor response throughout the study using RECIST v1.1 and/or iRECIST
Time Frame:1 year
Safety Issue:
Description:To assess the preliminary antitumor activity of IV administration of HB-201
Measure:Number of patients receiving IT HB-201 with tumor response throughout the study using RECIST v1.1 and/or iRECIST
Time Frame:1 year
Safety Issue:
Description:To assess the preliminary antitumor activity of IT administration of HB-201
Measure:Characterization of preliminary immunogenic properties of IV administration by intracellular staining and ELISpot assay.
Time Frame:1 year
Safety Issue:
Description:To characterize the preliminary immunogenic properties of IT administration of HB-201 followed by IV administration of HB-201 in patients with HPV 16+ confirmed cancers.
Measure:Characterization of preliminary immunogenic properties of IT administration
Time Frame:1 year
Safety Issue:
Description:To characterize the preliminary immunogenic properties of IT administration of HB-201 followed by IV administration of HB-201 in patients with HPV 16+ confirmed cancers.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hookipa Biotech

Trial Keywords

  • Vaccine
  • Gene Therepy
  • TheraT®
  • E7E6
  • HPV 16 E7E6
  • HNSCC
  • HPV 16+ head and neck squamous cell cancer
  • Oropharyngeal cancer
  • Penile cancer
  • Anal cancer
  • Cervical cancer
  • Vaginal cancer
  • Vulvar cancer

Last Updated

January 6, 2020