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