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

Recruiting now · Phase 2/Phase 3

Conditions studied: Oral Squamous Cell Carcinoma

In brief

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 facts

Study ID: NCT05893888
Run by: Privo Technologies
People needed: 40
Starts: 2024-11-07
Expected to finish: 2027-05-31
Last updated by the study team: 2026-04-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must meet all the following criteria to be eligible for the study:
Age: 18 years or older at the time of screening.
Diagnosis: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-N1, M0. This includes SCC of the lip with a significant mucosal component.
Tumor Accessibility: Tumor must be accessible for intratumoral injection, with no evidence of active infection.
Measurable Disease: Presence of clinically and/or radiologically measurable tumor.
Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Life Expectancy: Estimated life expectancy of at least 3 months.
Informed Consent: Ability and willingness to provide written informed consent.
Compliance: Ability to return to the study site for treatment visits as defined in the protocol.
Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.

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.
3b: Inclusion Criteria
Participants must meet all the following criteria to be eligible for the study:
Age: 18 years or older at the time of screening.
Diagnosis: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-T2, N0, M0.
Tumor Accessibility: Tumor must be accessible for intratumoral injections via a bronchoscope, with no evidence of active infection.
Measurable Disease: Presence of clinically and/or radiologically measurable tumor.
Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Life Expectancy: Estimated life expectancy of at least 3 months.
Informed Consent: Ability and willingness to provide written informed consent.
Compliance: Ability to return to the study site for treatment visits as defined in the protocol.
Contraception: For participants of childbearing potential, agreement to use two effective methods of contraception during the study period.

Where it is running

City of Hope National Medical Center — Duarte, California, United States (enrolling)
Miami Cancer Institute — Miami, Florida, United States (enrolling)
The University of Chicago — Chicago, Illinois, United States (enrolling)
The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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