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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180215
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hookipa Biotech

Brief Summary:
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 or disease Intervention/treatment Phase
HPV-Related Squamous Cell Carcinoma Drug: HB-201 intravenous administration Drug: HB-201 intratumoral administration on first cycle, followed by HB-201 intravenous administration on subsequent cycles Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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'
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) for IV administration [ Time Frame: 1 year ]
    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

  2. Recommended Phase 2 Dose (RP2D) for IT administration [ Time Frame: 1 year ]
    To determine the RP2D for IT administration of HB-201 in terms of safety and tolerability in patients with HPV 16+ confirmed cancers


Secondary Outcome Measures :
  1. Number of patients receiving IV HB-201 experiencing treatment-emergent adverse events. [ Time Frame: 1 year ]
    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.

  2. Number of patients receiving IT HB-201 experiencing treatment-emergent adverse events [ Time Frame: 1 year ]
    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.

  3. Number of patients receiving IV HB-201 with tumor response throughout the study using RECIST v1.1 and/or iRECIST [ Time Frame: 1 year ]
    To assess the preliminary antitumor activity of IV administration of HB-201

  4. Number of patients receiving IT HB-201 with tumor response throughout the study using RECIST v1.1 and/or iRECIST [ Time Frame: 1 year ]
    To assess the preliminary antitumor activity of IT administration of HB-201

  5. Characterization of preliminary immunogenic properties of IV administration by intracellular staining and ELISpot assay. [ Time Frame: 1 year ]
    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.

  6. Characterization of preliminary immunogenic properties of IT administration [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180215


Contacts
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Contact: General Hookipa contact +43 1 890 6360 office@hookipabiotech.com
Contact: Hookipa Backup Contact +1 332 207 4590

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Gilbert, Arizona, United States, 85234
Contact: Jiaxin Niu    480-256-5435    Jiaxin.niu@bannerhealth.com   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Michael Posner    212-659-5567    Marshall.posner@mssm.edu   
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Debra Richardson    214-645-4673    Debra-Richardson@ouhsc.edu   
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Rom Leidner    503-215-5696    Rom.Leidner@providence.org   
Sponsors and Collaborators
Hookipa Biotech
Investigators
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Principal Investigator: Igor Matushansky, MD, PhD Hookipa Biotech

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Responsible Party: Hookipa Biotech
ClinicalTrials.gov Identifier: NCT04180215    
Other Study ID Numbers: H-200-001
2019-000907-34 ( EudraCT Number )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hookipa Biotech:
HPV 16+ head and neck squamous cell cancer
Oropharyngeal cancer
Penile cancer
Anal cancer
Cervical cancer
Vaginal cancer
Vulvar cancer
Vaccine
Gene Therepy
TheraT®
E7E6
HPV 16 E7E6
HNSCC
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell