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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05594875




Registration number
NCT05594875
Ethics application status
Date submitted
18/10/2022
Date registered
26/10/2022
Date last updated
25/06/2024

Titles & IDs
Public title
A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Scientific title
An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
SHR-A1921-I-102-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR-1921

Experimental: SHR-1921 -


Treatment: Drugs: SHR-1921
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events (AEs)
Timepoint [1] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [2] 0 0
Number of subjects with laboratory tests findings of potential clinical importance
Timepoint [2] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [3] 0 0
Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
Timepoint [3] 0 0
Screening up to study completion, an average of 1 year
Primary outcome [4] 0 0
Measure ECG
Timepoint [4] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of SHR-1921
Timepoint [1] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [2] 0 0
Area under the concentration-time curve (AUC 0-8) from time 0 to infinity of SHR-1921
Timepoint [2] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [3] 0 0
Time to Cmax (Tmax) of SHR-1921
Timepoint [3] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [4] 0 0
Clearance of SHR-1921
Timepoint [4] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [5] 0 0
Terminal elimination half-life (t1/2) of SHR-1921
Timepoint [5] 0 0
Screening up to study completion, an average of 1 year
Secondary outcome [6] 0 0
Pharmacodynamics ("ADA" ) of SHR-1921.
Timepoint [6] 0 0
Screening up to study completion, an average of 1 year

Eligibility
Key inclusion criteria
1. Able and willing to provide a written informed consent
2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content
3. Male or female
4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy
5. ECOG performance status of 0-1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites
2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression
3. Has known history of other documented malignancy
4. Has known history of acquired immunodeficiency syndrome (AIDS)
5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade = 2 cardiac failure
6. Has active or prior documented interstitial pneumonia/interstitial lung disease
7. Has experienced Grade = 2 hemorrhage events within 4 weeks prior to the first dose
8. Has known active hepatitis B
9. Has known allergies to SHR-1921 component
10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2024
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment hospital [2] 0 0
Macquarie Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney South West Private Hospital - Sydney
Recruitment hospital [4] 0 0
ICON Cancer Centre - Brisbane
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
2170 - Sydney
Recruitment postcode(s) [4] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
Trial website
https://clinicaltrials.gov/study/NCT05594875
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05594875