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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT04319757
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)
* Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.
* Histologically confirmed HER2 expression.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Measurable or non-measurable evaluable disease according to RECIST 1.1
* Adequate hematologic and end-organ function at baseline
* Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air
Exclusion Criteria:
* Untreated central nervous system (CNS) metastases
* Multiple primary malignancies
* Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)
* Pregnant or lactating female
* Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment
* History of autoimmune or immune mediated symptomatic disease
* Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04319757
Study Brief:
Protocol Section:
NCT04319757