A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor

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.