Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04446260




Registration number
NCT04446260
Ethics application status
Date submitted
18/06/2020
Date registered
24/06/2020

Titles & IDs
Public title
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Scientific title
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
Secondary ID [1] 0 0
SHR-A1811-I-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-A1811

Experimental: Part 1 Dose escalation -

Experimental: Part 2 Indication expansion -


Treatment: Drugs: SHR-A1811
be administered via intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events (AEs)
Timepoint [1] 0 0
From Day1 to 90 days after last dose
Secondary outcome [1] 0 0
PK parameter: Tmax of SHR-A1811
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [2] 0 0
PK parameter: Cmax of SHR-A1811
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [3] 0 0
PK parameter: AUC0-t of SHR-A1811
Timepoint [3] 0 0
Through study completion, an average of 1 year
Secondary outcome [4] 0 0
Immunogenicity of SHR-A1811
Timepoint [4] 0 0
Through study completion, an average of 1 year
Secondary outcome [5] 0 0
Tumor response using RECIST 1.1
Timepoint [5] 0 0
From first dose to disease progression or death, whichever comes first, up to 30 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
Accrual to date
Final
396
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment hospital [3] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [4] 0 0
Nucleus Network - Melbourne
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Anhui
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Guangdong
Country [8] 0 0
China
State/province [8] 0 0
Henan
Country [9] 0 0
China
State/province [9] 0 0
Hubei
Country [10] 0 0
China
State/province [10] 0 0
Hunan
Country [11] 0 0
China
State/province [11] 0 0
Jiangsu
Country [12] 0 0
China
State/province [12] 0 0
Jilin
Country [13] 0 0
China
State/province [13] 0 0
Liaoning
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Sichuan
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Gyeonggi-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taichung
Country [21] 0 0
Taiwan
State/province [21] 0 0
Tainan
Country [22] 0 0
Taiwan
State/province [22] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu HengRui Medicine Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Atridia Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sherry Zhu, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+86 021-61053363
Fax 0 0
Email 0 0
xiaoyu.zhu@hengrui.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04446260