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:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04446260
Eligibility Criteria:
Inclusion Criteria:
* Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* LVEF ≥ 50% by either ECHO or MUGA
* Has adequate renal and hepatic function
* Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment
Exclusion Criteria:
* History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
* Known hereditary or acquired bleeding and thrombotic tendency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04446260
Study Brief:
Protocol Section:
NCT04446260