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.
⁃ 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.