RecruitingPhase 2Phase 3NCT05893888

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

Enrollment

40 participants

Start Date

Nov 7, 2024

Study Type

INTERVENTIONAL

Conditions

Oral Squamous Cell Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests two experimental treatments (PRV111 and PRV211) for oral cancer (cancer of the mouth or lip), with one arm targeting pre-cancerous lesions and another targeting early-stage invasive cancers that have not spread to distant organs. **You may be eligible if...** - You have pathologically confirmed carcinoma in situ (pre-invasive cancer) of the lip or oral cavity (Arm 1), OR early-to-intermediate stage invasive oral/lip cancer (T1–T3, no distant spread) (Arm 2) - You meet the general health and consent requirements for the study **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have a stage T4 tumor or extensive node involvement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRV211 (Intraoperative Cisplatin System)

PRV211 system is comprised of two parts, a liquid permeation enhancer (PE) and cisplatin patch. The permeation is brushed onto the resected tumor bed and after 5 minutes the patch can be applied directly over the same area. Apply up to 2 layers of the PRV211 system to the tumor bed post-resection. The duration of the PRV211 treatment takes approximately 10-20 minutes and then the surgeon can continue as planned with the rest of the standard of care procedure. The proposed starting dose is 0.5 mg/cm2 of cisplatin on the tumor bed. This approach can be safe and effective in preventing locoregional recurrence after surgery and eliminating high-risk factors for local recurrence, such as dysplasia at the margins.

DRUGPRV111 (Cisplatin Transmucosal System)

PRV111 (Cisplatin Transmucosal System) is a thin, 2-layer, matrix-type, transmucosal patch consisting of a chitosan matrix layer embedded with cisplatin loaded chitosan particles (CLPs) and a non-woven fabric adhesive unidirectional backing, which is applied to the matrix layer during manufacturing. The patch is self-adhesive. In addition to the PRV111 patch, a separately packaged Permeation Enhancer (PE) Powder for Reconstitution used in conjunction with PRV111. The reconstituted PE Solution is intended to improve the absorption of the cisplatin active ingredient and will be applied prior to patch application.

DRUGPRV131 (Cisplatin Intratumoral Injectable)

PRV131 is a nanoparticle-based cisplatin formulation designed for intratumoral administration. The product is supplied as a lyophilized powder and reconstituted with a separately packaged diluent to form a suspension for injection. The reconstituted suspension is administered directly into the tumor, with dosing customized based on tumor size and injection site distribution. Upon intratumoral administration, the nanoparticles facilitate deep tumor penetration and localized drug release, enabling high local cisplatin concentrations while minimizing systemic exposure.