StudyFinder
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
RECRUITING
18 years and over
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 trialGENETIC: Dose Level 1, VNX-202, GENETIC: Dose Level 2, VNX-202, GENETIC: Dose Level 3, VNX-202, GENETIC: Dose Level 4, VNX-202
HER2 Expressing Solid Tumors
HER2+ breast cancer, HER2+ gastric cancer, Other HER+ cancer, HER2-low cancer
Allen Reha - allen.reha@vironexis.com
NCT07192432