A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Other Cancers
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
- Documentation of confirmed HPV 16+ cancer via genotype testing.
- ≥ 1 measurable lesion by imaging for tumor response following RECIST
- ECOG performance status of 0 to 1.
- Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
- Screening laboratory values must meet protocol-specified criteria.
- Able to provide tumor tissue following last treatment, unless otherwise agreed. Treatment Group E or Group F:
- Documentation of confirmed head and neck squamous cell carcinoma.
- Eligible to receive pembrolizumab, per standard of care and product label.
- Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
- Group F: Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
- Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
- At least 1 non-irradiated measurable lesion documented through imaging.
- Metastatic central nervous system disease, and/or carcinomatous meningitis.
- Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
- Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met.
- Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
- Has a life expectancy of less than 3 months.
- Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
- Not meeting the protocol-specified washout periods for prohibited medications.
- Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
- Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
- Known history of acquired immunodeficiency syndrome. For patients in Groups E or F and certain backfill cohorts:
- History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
- History of/Presently having non-infectious pneumonitis requiring treatment.
- Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
- Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
- Meeting requirements of exclusion criteria for Treatment Group 3
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