A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors (NCT04446260) | Clinical Trial Compass
CompletedPhase 1
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
United States, Australia396 participantsStarted 2020-09-07
Plain-language summary
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 participate
Age range18 Years
SexALL
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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:
* 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