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

Conditions

• Oral Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• PRV211 (Intraoperative Cisplatin System) — DRUG
  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.
• PRV111 (Cisplatin Transmucosal System) — DRUG
  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.
• PRV131 (Cisplatin Intratumoral Injectable) — DRUG
  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.

Study Details

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

Key Dates

Start date

Nov 7, 2024

Status verified

Jun 2025

Primary completion

Oct 31, 2026

Completion

May 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity
  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)
• Experimental: Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity
  Arm 2 PRV211 Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting
• Experimental: Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as cli
  Intratumoral Injectable for Tumors of the Oral Cavity Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable.
• Experimental: Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as
  Intratumoral Injectable for Tumors of the Lung Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 6-7 months ]

Locations (4)

Find similar trials in Duarte, CA

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