RecruitingPhase 1Phase 2NCT07192432

Gene Therapy for HER-Positive Cancer (SENTRY-HER2)

A Phase 1/2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer


Sponsor

Vironexis Biotherapeutics Inc.

Enrollment

27 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This gene therapy trial (SENTRY-HER2) is testing a new treatment for people with HER2-positive cancers — cancers that have too much of a protein called HER2 on their surface. The trial has two parts: one for advanced or metastatic disease, and one for early-stage cancers at high risk of coming back. **You may be eligible if...** - You are 18 or older with a confirmed HER2-positive solid tumor - For Part 1: your cancer is advanced or metastatic and has progressed after prior treatment - For Part 2: you have early-stage HER2-positive cancer at high risk for relapse after standard or neoadjuvant treatment - Your general health score is 0 or 1 (fully active or mildly restricted) - Your heart, lungs, liver, kidneys, and blood counts are within required ranges - Your antibody levels to the gene therapy carrier (AAV capsid) are low enough **You may NOT be eligible if...** - You have active liver inflammation (elevated AST or ALT) - You have active brain or spinal fluid involvement of your cancer - You have a history of certain blood-clotting disorders or other disqualifying conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICDose Level 1, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

GENETICDose Level 2, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

GENETICDose Level 3, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion

GENETICDose Level 4, VNX-202

Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion


Locations(4)

Valkyrie Clinical Trials

Los Angeles, California, United States

SCRI Denver DDU at HealthOne

Denver, Colorado, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07192432