A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor

An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor

The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.

Inclusion Criteria:

1. ≥18 years of age;
2. Solid Tumor confirmed by histology or cytology;
3. ECOG score is 0 or 1;
4. An expected survival of ≥ 12 weeks;
5. At least one measurable lesion according to RECIST v1.1 criteria;
6. Have adequate renal and hepatic function;
7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

1. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
2. Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
3. History of immunodeficiency;
4. Clinically significant cardiovascular diseases;
5. Known or suspected interstitial lung disease;
6. Known hereditary or acquired bleeding thrombotic tendency;
7. Active hepatitis and liver cirrhosis;
8. Known allergic history of the drug components of this protocol;
9. History of neurological or psychiatric disorders.