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

Prior treatment

• 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).
• Live vaccine within 28 days (unless agreed otherwise between Sponsor and Investigator).
• Treatment with chemotherapy for cervical cancer, prior to planned chemoradiation.
• Prior allogeneic bone marrow transplantation or prior solid organ transplantation.

Other illness

• Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension.
• 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.
• 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)

Other

• All subjects:
• 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.

• 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.