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

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.

Inclusion Criteria: * 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 Criteria: * 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