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

March 7, 2024 updated by: Hookipa Biotech GmbH

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

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 by IV route.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 or unknown primary cancer site who are candidates for transoral surgery. Participants will receive a single intravenous dose of the study agent HB-201 prior to transoral surgery administered intravenously.

In Arm 2, the study will enroll cervical cancer subjects who have histologically confirmed newly diagnosed advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype clincal stages IB to IVB with plan for initial treatment of definitive chemoradiation. Participants will receive a single intravenous dose of HB-201 prior to the start of chemoradiation.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

  • Newly diagnosed, head and neck squamous cell carcinoma or undifferentiated carcinoma of the oropharynx origin or unknown primary cancer site, determined to be resectable.
  • AJCC v8.0 Tumor, Node, Metastasis (TNM) stage I-III, cT0- 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.

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.
  • 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)

• 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HB-201 Intravenously on Day 1
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.
Drug: HB-201 IV
HB-201 given IV, one (1) time, on day 1.
Drug: HB-201 IV
HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation.
Experimental: HB-201 Intravenously 7 to 14 days before chemoradiation
Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.
Drug: HB-201 IV
HB-201 given IV, one (1) time, on day 1.
Drug: HB-201 IV
HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Approximately 6-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evidence of response to HB-201
Time Frame: Approximately 6-8 weeks
Change in tumor size per RECIST v1.1
Approximately 6-8 weeks
Toxicity profile of HB-201
Time Frame: Approximately 30 days post HB-201 administration
Number and type of adverse events per CTCAE v5.0
Approximately 30 days post HB-201 administration
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Time Frame: Approximately 6-8 weeks
Pre and post administration of HB-201
Approximately 6-8 weeks
Investigate metabolic and proteomics changes in serum and plasma.
Time Frame: Approximately 6-8 weeks
Pre and post administration of HB-201
Approximately 6-8 weeks
Investigate the t-cell receptor repertoire diversity and clonality.
Time Frame: Approximately 6-8 weeks
Pre and post administration of HB-201.
Approximately 6-8 weeks
Other Exploratory Biomarker research may be conducted on any tumor tissue and/or blood samples collected during the study.
Time Frame: Approximately 6-8 weeks
Approximately 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hookipa Biotech GmbH

Investigators

  • Study Director: Chief Medical Officer, Hookipa Biotech GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-200-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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