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

This study is testing a gene therapy called VNX-202 for people with HER2-positive solid tumors. VNX-202 is designed to help your body's immune cells (T-cells) find and kill cancer cells that have the HER2 protein. It works by delivering a special gene that tells your liver to continuously make a protein (GP202) that connects T-cells to HER2-positive cancer cells. The main goal is to see how safe VNX-202 is, by tracking any side effects. You may be able to join if you are 18 or older and have HER2-positive cancer that has either spread or is at high risk of coming back. The study plans to enroll 27 participants, but its current status is unclear.

Study design
This is a first-in-human, open-label study with a dose-escalation and expansion design. It will involve approximately 27 participants.
What's involved
You will receive a single intravenous (IV) infusion of VNX-202. The study will involve monitoring for side effects for up to 5 years after your infusion.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) and serious adverse events for up to 5 years after receiving the dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07192432

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vironexis Biotherapeutics Inc.
~27 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Dose Level 1, VNX-202Dose Level 2, VNX-202Dose Level 3, VNX-202Dose Level 4, VNX-202

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Measured over Change from Baseline to Year 5 post dosing

Conditions

HER2 Expressing Solid Tumors

Explore related trials

Breast CarcinomaGastric CarcinomaSolid NeoplasmAAV capsidERBB2 Gene

Where it's being run

11 sites across 11 states
California1
Colorado1
Florida1
Minnesota1
New Jersey1
New York1
Ohio1
Pennsylvania1

Who to contact

Allen Reha
[email protected]
908-938-6019
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age: ≥18 years of age
Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol
Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment
Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment
AAV specified capsid total antibody ≤1:400
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Protocol-specified ranges for renal, liver, cardiac and pulmonary function
Protocol-specified ranges for hematology parameters

Exclusion

Hepatoxicity (AST or ALT \> 2x upper limit of normal)
Known active CNS or leptomeningeal disease
History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy
Pregnant or nursing (lactating) women
History of other malignancy within 5 years prior to screening as defined in protocol
History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial

What this trial measures

  • Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)Change from Baseline to Year 5 post dosing