SHR-1921
DrugSubject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
NCT Number: NCT05594875
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Macquarie Hospital, Sydney, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
Time frame: Screening up to study completion, an average of 1 year
To check the numbers of AEs happened during the course of trial.
Time frame: Screening up to study completion, an average of 1 year
To check the Clinically significant and non clinically significant abnormal values during the course of trial.
Time frame: Screening up to study completion, an average of 1 year
To measure the vital signs on regular basis for all study participants
Time frame: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
Time frame: Screening up to study completion, an average of 1 year
To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma.
Time frame: Screening up to study completion, an average of 1 year
To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma
Time frame: Screening up to study completion, an average of 1 year
To check what time will it take to reach the maximum contraction of SHR-1921 in study participants
Time frame: Screening up to study completion, an average of 1 year
The apparent clearance of SHR-1921(CL/F) of SHR-1921
Time frame: Screening up to study completion, an average of 1 year
To check how much time SHR-1921 will take to eliminate half of it's concentration from participants.
Time frame: Screening up to study completion, an average of 1 year
To check the" Anti Drug Antibody" develops in participants against the SHR-1921 through blood sample
Atridia Pty Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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