Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

ID#: NCT05826275

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: June 20, 2023

End Date: December 01, 2024

Contact Information:
Julio Juarez
Neil J Clendeninn, MD, PhD
Summary: 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.

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