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

  • End date
    Dec 7, 2023
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 7 January 2022


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.

Condition Advanced Solid Tumors
Treatment SHR-A1811
Clinical Study IdentifierNCT04446260
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on7 January 2022


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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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