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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Solid Tumors
Age (in years)
18+
Phase
Phase 1
Participants needed
226
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov identifier
NCT04446260
Study number
SHR-A1811-I-101
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