A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
- Registration Number
- NCT04446260
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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 malignant solid tumor subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1 Dose escalation SHR-A1811 - Part 2 PK expansion SHR-A1811 - Part 3 Indication expansion SHR-A1811 -
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (AEs) From Day1 to 90 days after last dose Frequency and seriousness of treatment emergent adverse events (TEAEs)
- Secondary Outcome Measures
Name Time Method PK parameter: Tmax of SHR-A1811 Through study completion, an average of 1 year Time to maximal concentration (Tmax) of SHR-A1811
PK parameter: Cmax of SHR-A1811 Through study completion, an average of 1 year Maximal concentration (Cmax) of SHR-A1811
PK parameter: AUC0-t of SHR-A1811 Through study completion, an average of 1 year AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
Immunogenicity of SHR-A1811 Through study completion, an average of 1 year Including anti-drug antibody and/or neutralizing antibody
Tumor response using RECIST 1.1 From first dose to disease progression or death, whichever comes first, up to 30 months RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months
Trial Locations
- Locations (35)
Fujian Cancer Hospital
🇨🇳Fujian, Fuzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Shanghai Jiao Tong University School of Medicine Renji Hospital
🇨🇳Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Montefiore-Einstein Center for Cancer Care
🇺🇸The Bronx, New York, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Macquarie University Hospital
🇦🇺Macquarie, New South Wales, Australia
Southern Oncology Clinical Research Unit
🇦🇺Bedford Park, South Australia, Australia
Peninsula and South Eastern Haematology & Oncology Group
🇦🇺Frankston, Victoria, Australia
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