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

  • End date
    Dec 11, 2022
  • participants needed
  • sponsor
    Hookipa Biotech GmbH
Updated on 11 February 2021


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.


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.

Condition HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer
Treatment HB-201 IT, HB-201 IV
Clinical Study IdentifierNCT04630353
SponsorHookipa Biotech GmbH
Last Modified on11 February 2021


Yes No Not Sure

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
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