- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446260
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
July 19, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
226
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sherry Zhu, MD, PhD
- Phone Number: +86 021-61053363
- Email: xiaoyu.zhu@hengrui.com
Study Contact Backup
- Name: Catherine Rong
- Phone Number: +86 021-61053363
- Email: shangyi.rong@hengrui.com
Study Locations
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-
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Melbourne, Australia, 3004
- Recruiting
- Alfred Hospital
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Principal Investigator:
- Mark Voskoboynik
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-
New South Wales
-
Macquarie, New South Wales, Australia, 2109
- Recruiting
- Macquarie University Hospital
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Principal Investigator:
- John Park
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-
South Australia
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Bedford Park, South Australia, Australia, 5042
- Recruiting
- Southern Oncology Clinical Research Unit
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Principal Investigator:
- Amitesh Roy
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Victoria
-
Frankston, Victoria, Australia, 3199
- Recruiting
- Peninsula and South Eastern Haematology & Oncology Group
-
Principal Investigator:
- Vinod Ganju
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Melbourne, Victoria, Australia, 3004
- Active, not recruiting
- Nucleus Network
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-
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Anhui
-
Bengbu, Anhui, China, 233000
- Recruiting
- The First Affiliated Hospital of Bengbu Medical college
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-
Beijing
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Beijing, Beijing, China, 100021
- Not yet recruiting
- Cancer Hospital Chinese Academy of Medical Sciences
-
-
Guangdong
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Guangzhou, Guangdong, China, 510120
- Recruiting
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Guangzhou, Guangdong, China, 510120
- Recruiting
- Nanfang Hospital
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-
Henan
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Zhengzhou, Henan, China, 450003
- Recruiting
- Henan Cancer Hospital
-
-
Hubei
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Wuhan, Hubei, China, 430079
- Recruiting
- Hubei Cancer Hospital
-
Wuhan, Hubei, China, 430062
- Recruiting
- Zhongnan hospital of Wuhan University
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital Central South University
-
Changsha, Hunan, China, 410031
- Recruiting
- Hunan Cancer hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210008
- Recruiting
- Nanjing Drum Tower Hospital
-
-
Jilin
-
Changchuan, Jilin, China, 130021
- Not yet recruiting
- The First Hospital of Jilin University
-
-
Liaoning
-
Shengyang, Liaoning, China, 110022
- Recruiting
- Shengjing Hospital of China Medical University
-
-
Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Shanghai, Shanghai, China, 200032
- Not yet recruiting
- Fudan Unversity Zhongshan Hospital
-
-
Sichuan
-
Chengdu, Sichuan, China, 610042
- Not yet recruiting
- Sichuan Cancer Hospital
-
-
Tianjin
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Tianjin, Tianjin, China, 300181
- Recruiting
- Tianjin medical university cancer institute&hoospital
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-
Zhejiang
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Hangzhou, Zhejiang, China, 310014
- Recruiting
- Zhejiang Provincial People's Hospital
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Hangzhou, Zhejiang, China, 310014
- Recruiting
- The Second Affiliated Hospital Zhejiang University School of Medicine
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-
-
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Seoul, Korea, Republic of, 3080
- Recruiting
- Seoul National University Hospital
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Seoul, Korea, Republic of, 5505
- Recruiting
- Asan Medical Center
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-
Gyeonggi-do
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Seongnam, Gyeonggi-do, Korea, Republic of, 13620
- Recruiting
- Seoul National University Bundang Hospital
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-
-
-
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Taichung, Taiwan, 40447
- Recruiting
- China Medical University Hospital
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Tainan, Taiwan, 70457
- Recruiting
- National Cheng Kung University Hospital
-
Principal Investigator:
- Chia-Jui Yen
-
Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital, Linkou
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-
-
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New York
-
Bronx, New York, United States, 10461
- Recruiting
- Montefiore-Einstein Center for Cancer Care
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Contact:
- Andreas Kaubisch
- Phone Number: 718-920-4826
- Email: Akaubisc@montefiore.org
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Ohio
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Canton, Ohio, United States, 44718
- Withdrawn
- Gabrail Cancer Center
-
-
South Carolina
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Greenville, South Carolina, United States, 29605
- Recruiting
- Greenville Hospital System
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Principal Investigator:
- Ki Chung
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Greenville, South Carolina, United States, 29605
- Completed
- Prisma-Health Cancer Institute
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Texas
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Dallas, Texas, United States, 75230
- Recruiting
- Mary Crowley Cancer Research
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Principal Investigator:
- Minal Barve
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Houston, Texas, United States, 77030
- Withdrawn
- Center for Oncology and Blood Disorders
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1 Dose escalation
|
be administered via intravenous (IV) infusion
|
Experimental: Part 2 Indication expansion
|
be administered via intravenous (IV) infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of adverse events (AEs)
Time Frame: From Day1 to 90 days after last dose
|
Frequency and seriousness of treatment emergent adverse events (TEAEs)
|
From Day1 to 90 days after last dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK parameter: Tmax of SHR-A1811
Time Frame: Through study completion, an average of 1 year
|
Time to maximal concentration (Tmax) of SHR-A1811
|
Through study completion, an average of 1 year
|
PK parameter: Cmax of SHR-A1811
Time Frame: Through study completion, an average of 1 year
|
Maximal concentration (Cmax) of SHR-A1811
|
Through study completion, an average of 1 year
|
PK parameter: AUC0-t of SHR-A1811
Time Frame: 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
|
Through study completion, an average of 1 year
|
Immunogenicity of SHR-A1811
Time Frame: Through study completion, an average of 1 year
|
Including anti-drug antibody and/or neutralizing antibody
|
Through study completion, an average of 1 year
|
Tumor response using RECIST 1.1
Time Frame: 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
|
From first dose to disease progression or death, whichever comes first, up to 30 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2020
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 24, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-A1811-I-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumors
-
AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States, Australia
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
Clinical Trials on SHR-A1811
-
Henan Cancer HospitalRecruitingHER2 Low Breast CarcinomaChina
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
-
Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.Not yet recruitingER Positive/HER2 Low Breast CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Recruiting
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruitingGastric Cancer | Colorectal CancerChina
-
Fudan UniversityRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingHER2-expressing Advanced Solid TumorsChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Solid TumorsChina
-
Shandong Suncadia Medicine Co., Ltd.Not yet recruiting