A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck
squamous cell carcinoma (HNSCC) patients.
- Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in
this phase to identify the recommended intratumor injection volumes of PEP503.
- Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18
additional patients will be enrolled at the recommended volume level to evaluate for
safety and efficacy.