Lead Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Male or female subject \>= 18 years;
•Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;
•Adequate organ function assessed within 7 days prior to first trial treatment
•ECOG score 0 or 1;
•Left ventricular ejection fraction (LVEF) ≥ 50% at baseline;
•Life expectancy \>3 months

•Untreated active CNS metastasis or leptomeningeal metastasis;
•Uncontrolled tumor-related pain;
•Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment;
•Major surgery for any reason within 28 days;
•Curative radiation within 3 months of the first dose of trial treatment;
•History of uncontrolled intercurrent illness;
•Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance

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