A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors

About the study

This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
LVEF ≥ 50% by either ECHO or MUGA
Has adequate renal and hepatic function
Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

EXCLUSION CRITERIA

Exclusion Criteria:

History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
Known hereditary or acquired bleeding and thrombotic tendency