Status:
COMPLETED
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsors:
Atridia Pty Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2025
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT04446260
Start Date
September 7 2020
End Date
June 4 2025
Last Update
September 15 2025
Active Locations (35)
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1
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, United States, 10461
2
Greenville Hospital System
Greenville, South Carolina, United States, 29605
3
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
4
Macquarie University Hospital
Macquarie, New South Wales, Australia, 2109