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
Vironexis Biotherapeutics Inc.
27 participants
Nov 18, 2025
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
Inclusion Criteria9
- 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 Criteria6
- 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
Interventions
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Adeno-associated viral vector encoding the CD3/HER2 Bi-Specific T-Cell Engager (AAV.CD3/HER2), Single IV Infusion
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07192432