This first-in-human, open-label Phase 1/2 trial assesses the safety and efficacy of the gene therapy VNX-202 in patients with HER2-positive cancers. The study includes dose-escalation and expansion parts across four dose levels. Participants are adults aged 18 or older with a histologically or cytologically confirmed HER2-positive solid tumor; Part 1 enrolls those with advanced or metastatic disease that progressed during or after prior treatment, while Part 2 enrolls early stage HER2-positive disease.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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