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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT04162327
Eligibility Criteria:
Inclusion Criteria:
* Written (signed) informed consent.
* Life expectancy ≥12 weeks.
* Patients with HER2-expressing advanced solid tumor who failed on current standard of care
* According to RECIST 1.1, at least one measurable lesion (radiation-naïve) exists.
* ECOG performance status 0-1.
* Adequate organ and marrow function evaluated by laboratory tests as follow:
* CBC: absolute neutrophil count (ANC) ≥ 1.0×109/L (Ia stage) or 1.5×109/L (Ib stage); Platelet (PLT) ≥ 75×109/L; Hemoglobin (HGB) ≥ 9.0g/L;
* Liver function: Total bilirubin (TBIL) ≤ 1.5×upper limit of normal value (ULN) for patients without hepatic metastases, ≤ 2×ULN for patients with hepatic metastases or Gilbert syndrome; Alanine aminotransferase (ALT) ≤ 2.5×ULN; Aspartate transferase (AST) ≤ 2.5×ULN;
* Renal function: Clearance of creatinine (CCr) by Cockcroft-Gault formula or 24-hour urine collection ≥ 50ml/min;
* Urinalysis: urine protein \< 2+ or urine protein in 24-hour urine collection \< 1g;
* Coagulation function: activated partial thromboplastin time (APTT）≤ 1.5×ULN; international normalized ratio (INR）≤ 1.5
* left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography;
* Accumulative exposure to doxorubicin ≤ 360mg/m2; accumulative exposure to epirubicin ≤ 720mg/m2;
* Agree to use an approved contraceptive method during the treatment period, until 180 days after last dose of treatment.
* Post-menopause female subject or pre-menopause female with negative HCG level in urine or blood.
Exclusion Criteria:
* Any greater than NCI CTCAE 0/1 adverse event exists within 4 weeks before enrollment, not including hair loss and fatigue;
* Received major surgery or having unhealed wound, ulcer, or bone fracture;• Received whole pelvic radiation;
* Plan to receive any other anti-cancer therapy not specified in the protocol, except for palliative radiotherapy;
* CNS metastasis, spinal compression, or carcinomatous meningitis
* Active autoimmune disease or inflammatory disorders.
* Primary immunodeficiency diseases;
* Pregnant or breast-feeding female.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04162327
Study Brief:
Protocol Section:
NCT04162327