Actively Recruiting
A Phase 1/2/3 Multicenter Study Evaluating the PRV Platform of Localized Nanoengineered Therapies for Oral Cavity and Lung Cancers
Led by Privo Technologies · Updated on 2026-04-23
40
Participants Needed
4
Research Sites
34 weeks
Total Duration
On this page
Sponsors
P
Privo Technologies
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of three nanoengineered therapies—PRV111, PRV211, and PRV131—in 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.
CONDITIONS
Brief Title
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of carcinoma in situ or T1-T3 oral cavity squamous cell carcinoma, or malignant tumor in the lungs (primary or secondary)
- Tumors accessible and suitable for surgical resection within 8 weeks
- Clinically or radiologically measurable tumors
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 3 months
- Willingness and ability to provide written informed consent
- Ability to attend treatment and follow-up visits as scheduled
- For participants of childbearing potential, agreement to use two effective methods of contraception during the study period
- Absence of serious underlying medical conditions that impair study participation
You will not qualify if you...
- Not eligible for standard-of-care surgery
- Prior history of invasive squamous cell carcinoma (Arm 1)
- Tumors involving marginal gingiva (Arm 1)
- Previous radiotherapy for squamous cell carcinoma of the oral cavity (Arm 1)
- Systemic chemotherapy for head and neck SCC less than 2 years prior (Arm 1)
- Concurrent malignancy except localized skin SCC or basal cell carcinoma
- Exposure to investigational agents within 3 months prior to screening
- Known allergy or intolerance to platinum-containing agents or study excipients
- Active uncontrolled infections requiring systemic therapy including HIV, syphilis, hepatitis B or C
- Uncontrolled illness risking safety or compliance
- Known or suspected pregnancy, planned pregnancy, or lactation
- Medical or psychiatric conditions compromising consent ability
- Known oral submucous fibrosis or trismus (Arm 1)
- Abnormal renal, hepatic, or cardiac function (QTc prolongation limits)
- Bone involvement by tumor (Stage T4)
- Diagnosis of salivary gland cancer (Arm 3a)
- History of oral or lung cancers nonresponsive to radiation or platinum chemotherapy within 12 months
- Multifocal invasive oral squamous cell carcinoma (Arm 3a)
- Active concurrent malignancies requiring systemic therapy (Arm 3b)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 to 4 weeks depending on treatment and surgery timing
Participants receive one of the following treatments based on their assigned arm: PRV111 topical patch applied repeatedly with assessments prior to surgery, PRV211 intraoperative chemotherapy applied to the tumor bed immediately after surgical excision, or PRV131 intratumoral injections administered 1 to 3 times before surgery depending on tumor location and size.
At least 3 treatment visits for PRV111; 1 intraoperative treatment visit for PRV211; 1 to 3 intratumoral injection visits for PRV131 approximately 1 to 2 weeks apart
Duration - Up to 12 to 14 months
Participants are monitored post-treatment and post-surgery to assess safety, tumor response, recurrence, and durability of treatment effect.
Visits for safety and efficacy assessments over 12 to 14 months
Trial Site Locations
Total: 4 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
3
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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