Phase 2/3Recruiting
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
A Phase 1/2/3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers
- Sponsor
- Privo Technologies (Industry)
- Enrolment
- 40 planned
- Conditions
- Oral Squamous Cell Carcinoma
- Interventions
- PRV211 (Intraoperative Cisplatin System); PRV111 (Cisplatin Transmucosal System); PRV131 (Cisplatin Intratumoral Injectable)
- Ages
- adults, older adults
- Registry
- NCT05893888
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Overall Response Rate (ORR)
- Safety assessed via dose-limiting toxicities
History
Study completion expected
Primary completion
Last registry update
Started
Registered