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

Primary Purpose

HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
HB-201 IV
HB-201 IV
Sponsored by
Hookipa Biotech GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer focused on measuring HPV, Oropharynx Cancer, Cervical Cancer, Intravenous, Lymphocytic Choriomeningitis Virus, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Transoral Surgery, Window of Opportunity, HPV 16+ cervical cancer, HPV 16+ head and neck squamous cell cancer, HPV 16 E7E6, E7E6

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Froedtert Hospital and the Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HB-201 Intravenously on Day 1

HB-201 Intravenously 7 to 14 days before chemoradiation

Arm Description

Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.

Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.

Outcomes

Primary Outcome Measures

Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.
Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2020
Last Updated
October 9, 2023
Sponsor
Hookipa Biotech GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04630353
Brief Title
A Study HB-201 in Patients With Newly Diagnosed HPV16+ Oropharynx or Locally Advanced Cervical Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hookipa Biotech GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 by IV route.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
Keywords
HPV, Oropharynx Cancer, Cervical Cancer, Intravenous, Lymphocytic Choriomeningitis Virus, Medical College of Wisconsin Cancer Center, Medical College of Wisconsin, Transoral Surgery, Window of Opportunity, HPV 16+ cervical cancer, HPV 16+ head and neck squamous cell cancer, HPV 16 E7E6, E7E6

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HB-201 Intravenously on Day 1
Arm Type
Experimental
Arm Description
Patients with resectable stage I-III, HPV 16+ genotype squamous cell cancer of the oropharynx or unknown primary cancer site.
Arm Title
HB-201 Intravenously 7 to 14 days before chemoradiation
Arm Type
Experimental
Arm Description
Patients with newly diagnosed HPV 16+ genotype advanced cervical cancer, clinical stages IB to IVB with plan for initial treatment of definitive chemoradiation.
Intervention Type
Drug
Intervention Name(s)
HB-201 IV
Intervention Description
HB-201 given IV, one (1) time, on day 1.
Intervention Type
Drug
Intervention Name(s)
HB-201 IV
Intervention Description
HB-201 given IV, one (1) time, 7 to 14 days prior to definitive chemoradiation.
Primary Outcome Measure Information:
Title
Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.
Description
Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).
Time Frame
Approximately 6-8 weeks
Secondary Outcome Measure Information:
Title
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Description
Pre and post administration of HB-201
Time Frame
Approximately 6-8 weeks
Title
Investigate metabolic and proteomics changes in serum and plasma.
Description
Pre and post administration of HB-201
Time Frame
Approximately 6-8 weeks
Title
Investigate the t-cell receptor repertoire diversity and clonality.
Description
Pre and post administration of HB-201.
Time Frame
Approximately 6-8 weeks
Title
Clinical evidence of response to HB-201
Description
Change in tumor size per RECIST v1.1
Time Frame
Approximately 6-8 weeks
Title
Toxicity profile of HB-201
Description
Number and type of adverse events per CTCAE v5.0
Time Frame
Approximately 30 days post HB-201 administration
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
General Hookipa Contact
Phone
1-866-544-8544
Email
hookipa@careboxhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Backup Hookipa Contact
Email
clinicaltrials@hookipapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Hookipa Biotech GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Feffer
Email
CCCTO@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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