Clinical Research Directory

Inclusion Criteria: * Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\~1; The expected survival is over 3 months. * Phase Ib 1. Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification; 2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment; 3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria * Phase II 1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes: 2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines; 3. at least one measurable lesion that meets the RECIST 1.1 criteria. * Major organs are functioning normally. * Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study. Exclusion Criteria: * Have occured other malignant tumors within 3 years prior to first dose. * Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment; * Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose; * Long-term unhealed wounds or fractures; * Arterial/venous thrombosis events occurred within 6 months before the first dose; * Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders; * Subject with any severe and/or uncontrolled disease; * Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug; * Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose; * Severe bone injury due to bone metastasis; * Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis; * In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \<50% or absolute LVEF decreased \>15%; * Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \>360 mg/m2; * Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy * Patients with severe hypersensitivity after the use of monoclonal antibodies; * Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.