Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT07192432
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07192432
Study Brief:
Protocol Section:
NCT07192432