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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    226
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 26 January 2021

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.

Details
Condition Advanced Solid Tumors
Treatment SHR-A1811
Clinical Study IdentifierNCT04446260
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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