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

NCT05893888 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CLN-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Oral Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  Proportion of treated tumors that have a response to PRV111 treatment. Response is defined as either or both: 1) histopathological downgrade of the disease such as partial or complete response as determined by post-treatment biopsies compared to baseline, or 2) clinically measurable tumor volume reduction from baseline of 30% or more from baseline.

  6-7 months

• Safety assessed via dose-limiting toxicities

  Determine a safe dose of PRV211 (Intraoperative Cisplatin System) under the conditions of the trial. For the purpose of safety detection, if greater than 33% of subjects being evaluated for safety present with dose-limiting toxicities (DLTs), the study drug is deemed unsafe.

  1-month post-surgery and through study completion, ~12-14 months

Secondary Outcomes (2)

• Event Free Survival

  through study completion, ~12-14 months

• Pharmacokinetics: platinum levels in blood

  through study completion, ~12-14 months

Study Arms (4)

Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity

EXPERIMENTAL

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)

Drug: PRV111 (Cisplatin Transmucosal System)

Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity

EXPERIMENTAL

Arm 2 PRV211 Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting

Drug: PRV211 (Intraoperative Cisplatin System)

Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as cli

EXPERIMENTAL

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.

Drug: PRV131 (Cisplatin Intratumoral Injectable)

Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as

EXPERIMENTAL

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.

Drug: PRV131 (Cisplatin Intratumoral Injectable)

Interventions

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.

Also known as: Cisplatin

Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity

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.

Also known as: Cisplatin

Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity

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.

Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as cli; Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in the study, an individual must meet all of the following criteria:
• Diagnosis 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
• 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).
• Clinically and/or radiologically measurable tumor.
• Eastern Collaborative Oncology Group Performance Status of ≤2.
• Male and female subjects of childbearing potential must agree to use 2 methods of effective contraception from screening and for at least 30 days after the final dose of investigational product. Appropriate birth control is defined as barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, or naturally or surgically sterile (with documentation in the subject's medical records). Postmenopausal women are defined as presenting at least 12 months' natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential must be non-lactating and have a negative serum hCG within 14 days of treatment initiation.
• Absence of any serious underlying medical conditions which could impair the ability of the subject to participate in the study.
• Have a life expectancy of ≥3 months.
• Willing and able to provide written informed consent.
• Able to return to study site for treatment and follow-up visits as defined in the Protocol.
• An individual who meets any of the following criteria will be excluded from participation in the study:
• Subjects that are not eligible for surgery as SOC.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• 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).
• Other Cancers: Diagnosis of salivary gland cancer.
• Prior Treatments: History of oral cancers that were nonresponsive to radiation or platinum-based chemotherapy within the past 12 months.
• Multifocal Disease: Presence of multifocal invasive oral squamous cell carcinoma (OSCC).
• Investigational Agents: Exposure to any investigational agent within 3 months prior to screening.
• Allergies: Known allergy or hypersensitivity to platinum-containing agents or any excipients in the study drug, or known intolerance to prior platinum-based therapy that would preclude re-exposure.
• Infections: Active, uncontrolled infections requiring systemic therapy, including but not limited to HIV, syphilis, hepatitis B, or hepatitis C.
• Comorbid Conditions: Uncontrolled intercurrent illness that would pose a risk to subject safety, interfere with study objectives, or limit compliance, as determined by the investigator.
• Pregnancy and Lactation: Known or suspected pregnancy, planned pregnancy, or current lactation.
• Consent Capacity: Any medical or psychiatric condition that may compromise the ability to provide written informed consent.
• Participants must meet all the following criteria to be eligible for the study:

Sponsors & Collaborators

• Privo Technologies: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Miami Cancer Institute

Miami, Florida, 33176, United States

RECRUITING

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1/2/3 Multicenter Study Evaluating the PRV Platform

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: November 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)