Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Official Title: Phase 1/2, Open-Label, Safety and Efficacy, Tolerability, Anti-Tumor Effects, Systemic Exposure, and Device Technical Effects of PRV211 in Subjects With T2-T3 Oral Squamous Cell Carcinoma Amenabl
Brief Summary:
PRV211 is a sterilized nano engineered delivery system intended for intraoperative chemotherapy treatment for all solid tumor surgeries immediately following surgical excision.
The goal is to treat the tumor bed locally, eliminating any remaining micro metastases or close margins that are unable to be fully resected while avoiding system circulation.
This study will enroll up to 40 subjects.
In this study both safety and efficacy will be evaluated.
All subjects will be monitored for possible DLTs.