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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Toragen, Inc.
• Treatments: Pembrolizumab

Criteria

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