Study of PRV111, PRV211, and PRV131 Nanoengineered Therapies for Oral and Lung Cancers Evaluating Safety and Effectiveness in Different Treatment Approaches

What this Trial Is About

Researchers are evaluating the safety and effectiveness of three nanoengineered therapiesPRV111, PRV211, and PRV131in patients with oral cavity and lung cancers. The study includes patients with various stages of carcinoma in situ and squamous cell carcinoma confirmed by pathology, aiming to assess localized delivery of cisplatin directly to tumor sites. The trial is conducted in multiple phases and evaluates response rates and safety outcomes over time. The study has three arms Arm 1 uses PRV111, a self-adhesive topical patch applied over the tumor region combined with a permeation enhancer to improve drug absorption. Arm 2 involves PRV211, a system applied intraoperatively to the resected tumor bed to target residual cancer cells locally. Arm 3 administers PRV131 as an injectable nanoparticle suspension directly into tumors of the oral cavity or lungs, with dose escalation to find a safe and effective dose. Treatments are tailored based on tumor size and location. Participants undergo screening to confirm diagnosis and suitability for surgery. They will have tumor assessments including biopsies, imaging, and photo documentation throughout treatment. The trial measures overall response rate and safety through dose-limiting toxicities at defined time points up to 12-14 months post-treatment. Follow-up includes monitoring for recurrence, pharmacokinetics of platinum levels, and overall event-free survival. Regular visits and surgical procedures are part of the study schedule.

A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers