Arm 1 ( Phase 2/3 Run in ):
PRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017)
Arm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting
Arm 3 (Phase 1/2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable
Subject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0
Tumors for which the cytological and architectural changes upon histopathological assessment warrant surgical intervention
Adult subjects, men and women, defined by age ≥18 years at the time of screening.
Tumor must be accessible, with no evidence of infection or active bleeding.
Tumor is amenable to surgical resection within 8 weeks of screening visit (Visit 0).
Surgical Eligibility: Not eligible for standard-of-care (SOC) surgery.
Renal and Hepatic Function: Abnormal renal and hepatic functions as determined by the investigator.
Cardiac Function: Corrected QT interval (QTc) > 470 ms for women and > 450 ms for men.
Bone Involvement: Known bone involvement by the tumor (Stage T4).
Privo Technologies
Lead sponsor
National Cancer Institute (NCI)
Collaborator