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
- RECRUITING
- Sex
- All
- Target Recruitment
- 226
- 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 β₯ 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 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
PK parameter: Tmax of SHR-A1811 Through study completion, an average of 1 year Time to maximal concentration (Tmax) of SHR-A1811
Immunogenicity of SHR-A1811 Through study completion, an average of 1 year Including anti-drug antibody and/or neutralizing antibody
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
PK parameter: Cmax of SHR-A1811 Through study completion, an average of 1 year Maximal concentration (Cmax) of SHR-A1811
Trial Locations
- Locations (35)
Gabrail Cancer Center
πΊπΈCanton, Ohio, United States
Seoul National University Hospital
π°π·Seoul, Korea, Republic of
Macquarie University Hospital
π¦πΊMacquarie, New South Wales, Australia
Sun Yat-Sen Memorial Hospital, Sun Yat-sen University
π¨π³Guangzhou, Guangdong, China
Shengjing Hospital of China medical university
π¨π³Shengyang, Liaoning, China
The second affiliated hospital Zhejiang university school of medicine
π¨π³Hangzhou, Zhejiang, China
Fudan University Shanghai cancer center
π¨π³Shanghai, Shanghai, China
National Cheng Kung University Hospital
π¨π³Tainan, Taiwan
Hunan cancer hospital
π¨π³Changsha, Hunan, China
The First Hospital of Jilin University
π¨π³Changchuan, Jilin, China
Sichuan Cancer Hospital
π¨π³Chengdu, Sichuan, China
Tianjin medical university cancer institute&hoospital
π¨π³Tianjin, Tianjin, China
Chang Gung Memorial Hospital, Linkou
π¨π³Taoyuan, Taiwan
Prisma-Health Cancer Institute
πΊπΈGreenville, South Carolina, United States
Xiangya hospital central south university
π¨π³Changsha, Hunan, China
China Medical University Hospital
π¨π³Taichung, Taiwan
Asan Medical Center
π°π·Seoul, Korea, Republic of
Hubei cancer hospital
π¨π³Wuhan, Hubei, China
Greenville Hospital System
πΊπΈGreenville, South Carolina, United States
The first affiliated hospital of bengbu medical college
π¨π³Bengbu, Anhui, China
Henan cancer Hospital
π¨π³Zhengzhou, Henan, China
Seoul National University Bundang Hospital
π°π·Seongnam, Gyeonggi-do, Korea, Republic of
Fudan Unversity Zhongshan Hospital
π¨π³Shanghai, Shanghai, China
Zhongnan hospital of Wuhan university
π¨π³Wuhan, Hubei, China
Nanjing Drum Tower Hospital
π¨π³Nanjing, Jiangsu, China
Montefiore-Einstein Center for Cancer Care
πΊπΈBronx, New York, United States
Mary Crowley Cancer Research
πΊπΈDallas, Texas, United States
Center for Oncology and Blood Disorders
πΊπΈHouston, Texas, United States
Nucleus Network
π¦πΊMelbourne, Victoria, Australia
Nanfang Hospital
π¨π³Guangzhou, Guangdong, China
Zhejiang provincial people's hospital
π¨π³Hangzhou, Zhejiang, China
Alfred Hospital
π¦πΊMelbourne, Australia
Southern Oncology Clinical Research Unit
π¦πΊBedford Park, South Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Peninsula and South Eastern Haematology & Oncology Group
π¦πΊFrankston, Victoria, Australia