Gene Therapy Study for HER2-Positive Cancer (SENTRY-HER2)
Sponsor: Vironexis Biotherapeutics Inc.
ClinicalTrials ID:NCT07192432
This clinical trial is testing a new gene therapy called VNX-202 to see if it is safe and effective for patients with HER2-positive cancers. The study is in two parts and aims to find the best dose and understand how the treatment works in the body.
Patient Parameters
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Program Overview
This study is exploring a new gene therapy treatment, VNX-202, for patients with HER2-positive cancers. The therapy uses a virus to deliver a special protein that helps the immune system attack cancer cells. The study is divided into two parts: the first part will find the right dose, and the second part will test the treatment in more patients to see how safe and effective it is. Participants will be monitored for up to 5 years after receiving the treatment to check for safety and effectiveness.
Description
VNX-202 is a new type of gene therapy that uses a virus to help the body produce a protein called GP202. This protein targets HER2-positive cancer cells and helps the immune system's T cells destroy them. The therapy is given through a single IV infusion, and the liver then continuously releases GP202 into the bloodstream, maintaining steady levels without needing repeated doses.
The study has two parts. In Part 1, researchers will determine the best dose of VNX-202 by testing it on about 12 patients with advanced HER2-positive cancers that have not responded to previous treatments. This part will help find the minimum dose needed to achieve the desired effect without causing serious side effects.
Part 2 will begin after reviewing the results from Part 1. It will involve about 15 patients with early-stage HER2-positive cancers who are at high risk of the cancer returning or spreading, even after previous treatments. This part will include patients with breast cancer, gastric cancer, and other HER2-positive cancers. Researchers will continue to monitor patients for safety and effectiveness for up to 5 years after treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of HER2-positive solid tumor cancer.
- For Part 1: Have advanced or metastatic cancer that has worsened after previous treatments.
- For Part 2: Have early-stage HER2-positive cancer with a high risk of returning after standard treatment.
- Have a specific level of antibodies related to the therapy.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
- Meet specific health criteria for kidney, liver, heart, and lung function.
- Meet specific blood test criteria.
Exclusion Criteria
- Have liver damage with certain enzyme levels more than twice the normal limit.
- Have active cancer in the brain or spinal fluid.
- Have a history of certain blood or heart conditions, or nerve damage.
- Be pregnant or breastfeeding.
- Have had another type of cancer within the last 5 years.
- Have allergies to steroids or have had problems with steroid treatments.
- Be receiving other cancer treatments in a different clinical trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| SCRI Denver DDU at HealthOne | 80218 | Denver | Colorado |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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