Study of PRV111, PRV211, and PRV131 for Oral and Lung Cancers
This study is testing three different treatments for oral and lung cancers: PRV111, PRV211, and PRV131. PRV111 is a patch applied to the tumor area. PRV211 is a system used during surgery on the area where the tumor was removed. PRV131 is an injection given directly into the tumor. Researchers want to see how safe these treatments are and how well they work to shrink or control the cancer. You might be able to join if you are 18 to 100 years old and have certain types of oral cancer. The study aims to enroll 40 participants, but its current status is unclear.
- Study design
- This interventional study is not specified by phase and will enroll 40 participants. Participants will be assigned to one of three arms based on their disease stage.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be assessed for about 12-14 months, and the overall response rate will be measured at 6-7 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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What this trial measures
- Overall Response Rate (ORR)6-7 months
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.
- Safety assessed via dose-limiting toxicities1-month post-surgery and through study completion, ~12-14 months
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.