Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer

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: NCT04630353
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Hookipa Biotech GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This Window Of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered either by IT injection or by IV route.

Condition or disease Intervention/treatment Phase
HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer Drug: HB-201 IT Drug: HB-201 IV Early Phase 1

Detailed Description:

The window of opportunity, Study H-200-002, will examine the effects of study agent (HB-201) on subjects during the "window" between diagnosis of their cancer and their definitive cancer surgery or chemoradiation.

The study will be a 2-arm study design. In Arm 1, the study will enroll subjects with resectable stage I-III human papillomavirus 16 positive (HPV 16+) genotype squamous cell cancer of the oropharynx who are candidates for transoral surgery. Participants will receive a single dose of the study agent HB-201 prior to transoral surgery. Arm 1 will consist of 2 Cohort groups; Cohort 1 will enroll subjects receiving HB-201 as an intratumoral injection and Cohort 2 will enroll patients receiving HB-201 administered intravenously.

In Arm 2, the study will enroll cervical cancer subjects who have locally advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype. Subjects with advanced/metastatic disease that are previously untreated who are planning to undergo upfront chemoradiation for local control are eligible and will receive an intratumoral injection of HB-201 prior to the start of chemoradiation.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0 Trial of HB-201 for Subjects With Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or With Locally Advanced Cervical Cancer Treated With Chemotherapy and Radiation
Actual Study Start Date : July 28, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: HB-201 Intratumorally on Day 1
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx.
 Drug: HB-201 IT
Cohort 1: HB-201 given IT, one (1) time, on day 1.
Experimental: HB-201 Intravenously on Day 1
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx.
 Drug: HB-201 IV
Cohort 2: HB-201 given IV, one (1) time, on day 1.
Experimental: HB-201 Intratumorally 7 to 14 days before chemoradiation
Patients with cervical cancer who have locally advanced squamous cell carcinoma with HPV 16+ genotype.
 Drug: HB-201 IT
HB-201 will be administered IT, one (1) time, 7 to 14 days prior to definitive chemoradiation.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer. [ Time Frame: Approximately 6-8 weeks ]
    Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).

  2. Immunologic response comparing IV and IT administration. [ Time Frame: Approximately 6-8 weeks ]
    Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).


Secondary Outcome Measures :
  1. Measurement of messenger RNA and expression profiles in tumor specimens using RNA-sequencing (800 genes). [ Time Frame: Approximately 6-8 weeks ]
    Pre and post administration of HB-201

  2. Assessment of tumor mutational burden (TMB, MSI) in tumor specimens using whole exome sequencing. [ Time Frame: Approximately 6-8 weeks ]
    Pre and post administration of HB-201

  3. Measure TH1/TH2 proinflammatory cytokines (mesoscale multiplex discovery assay) to characterize metabolic / proteomic changes in serum / plasma [ Time Frame: Approximately 6-8 weeks ]
    Pre and post administration of HB-201

  4. Measure ctDNA to characterize changes in circulating tumor by NextGen sequencing. [ Time Frame: Approximately 6-8 weeks ]
    Pre and post administration of HB-201

  5. Characterize t-cell receptor repertoire diversity and clonality, by t-cell receptor sequencing. [ Time Frame: Approximately 6-8 weeks ]
    Pre and post administration of HB-201.

  6. Clinical evidence of response to HB-201 [ Time Frame: Approximately 6-8 weeks ]
    Change in tumor size per RECIST v1.1

  7. Toxicity profile of HB-201 [ Time Frame: Approximately 30 days post HB-201 administration ]
    Number and type of adverse events per CTCAE v5.0


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

All subjects:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Confirmed HPV 16+ (human papilloma virus 16 positive) genotype testing of cancer.
  • Disease-free for ≥ 2 years from other curatively treated cancers, with protocol-defined exceptions.
  • Evaluated by cardiologist and/or neurologist if protocol-defined cardiac or neurological event within the last 6 months.

HPV 16+ Oropharynx Cancer (Arm 1 Cohorts 1 and 2)

  • Newly diagnosed, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, determined to be resectable.
  • AJCC v8.0 Tumor, Node, Metastasis (TNM) stage I-III, cT1- T3, and cervical nodes N1-N3 based on clinical or radiographic criteria with no evidence of distant metastases.
  • No prior radiation above the clavicles.
  • Must have acceptable renal and hepatic function as defined per protocol.
  • Cohort 2 (intratumoral administration) only: must have a safe and accessible tumor lesion amenable for biopsy and IT administration.

HPV 16+ Cervical Cancer (Arm 2)

  • Newly diagnosed, histologically confirmed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma): International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation (platinum agent weekly with radiotherapy) for either curative intent or control of local (pelvic) disease.
  • No prior radiation to the abdomen or pelvis.
  • Must have a safe and accessible tumor lesion amenable for biopsy and IT administration.
  • Must have normal organ and marrow function as defined per protocol.
  • Must not have a known allergy to cisplatin, carboplatin, or compounds of similar biologic composition.

Exclusion Criteria:

All subjects:

  • Treatment with any systemic anticancer therapy within 3 years (unless agreed otherwise between the Sponsor and the Investigator).
  • Treatment with any chronic immunosuppressive medication within 6 months (unless agreed otherwise between the Sponsor and Investigator).
  • Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension.
  • Live vaccine within 28 days (unless agreed otherwise between Sponsor and Investigator).
  • Known diagnosis of acquired immunodeficiency syndrome (AIDS).
  • Positive Hepatitis B or Hepatitis C tests indicating acute or chronic infection.
  • Intercurrent illness likely to interfere with protocol therapy.
  • Female subjects who are pregnant or breastfeeding.
  • Female subjects of childbearing potential who do not agree to the use of highly effective contraception per protocol.
  • Male subjects with sexual partners of childbearing potential who do not agree to the use of protocol-defined contraception

HPV 16+ Oropharynx Cancer (Arm 1 Cohorts 1 and 2)

• Primary tumor or nodal metastasis fixed to the carotid artery, skull base, or cervical spine.

HPV 16+ Cervical Cancer (Arm 2)

  • Treatment with chemotherapy for cervical cancer, prior to planned chemoradiation.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04630353


Contacts
Layout table for location contacts
Contact: General Hookipa Contact +43 1 890 6360 office@hookipabiotech.com
Contact: Hookipa Backup Contact +1 332 207 4590

Locations
Layout table for location information
United States, Wisconsin
Froedtert Hospital and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Cancer Center Clinical Trials Office    414-805-8900    CCCTO@mcw.edu   
Principal Investigator: Stuart J Wong, MD         
Principal Investigator: William Bradley, MD         
Sub-Investigator: Joseph Zenga, MD         
Sub-Investigator: Aditya Shreenivas, MD         
Sub-Investigator: Bruce Campbell, MD         
Sub-Investigator: Michael Stadler, MD         
Sub-Investigator: Becky Massey, MD         
Sponsors and Collaborators
Hookipa Biotech GmbH
Investigators
Layout table for investigator information
Study Director: Chief Medical Officer Hookipa Biotech GmbH
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hookipa Biotech GmbH
ClinicalTrials.gov Identifier: NCT04630353    
Other Study ID Numbers: H-200-002
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hookipa Biotech GmbH:
HPV
Oropharynx Cancer
Cervical Cancer
Intratumoral
Intravenous
Lymphocytic Choriomeningitis Virus
Medical College of Wisconsin Cancer Center
 Medical College of Wisconsin
Transoral Surgery
Window of Opportunity
HPV 16+
HPV 16+ head and neck squamous cell cancer
HPV 16 E7E6
E7E6
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Oropharyngeal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases