Trial Review

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/ct2/show/NCT04446260




Registration number
NCT04446260
Ethics application status
Date submitted
18/06/2020
Date registered
24/06/2020
Date last updated
21/07/2023

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
226
Accrual to date
Final
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04446260
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04446260