Overview

This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.

Eligibility

Inclusion Criteria:

• Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic
• Life expectancy of at least 3 months
• Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies

Exclusion Criteria:

• Active CNS metastases
• Have any history of seizure disorder or are taking prophylactic seizure medication
• Have an active viral, bacterial, or fungal infection