The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
SHR-A2102 for injection
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective Response Rate (ORR)
Assessed by Investigator according to RECIST 1.1 criteria.
Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Duration of response (DoR)
Assessed by Investigator according to RECIST 1.1 criteria.
Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Disease control rate (DCR)
Assessed by Investigator according to RECIST 1.1 criteria.
Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Time to response (TTR)
Assessed by Investigator according to RECIST 1.1 criteria.
Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Progression free survival (PFS)
Assessed by Investigator according to RECIST 1.1 criteria.
Time frame: Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
Time frame: follow up once every 60 days. Up to approximately 36 months.
12 month survival rate
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Survival rate within one year.
Time frame: follow up once every 60 days. Up to approximately 24 months.
Adverse Events (AEs)
Include incidence,grade(judged according to NCI-CTCAE V5.0 standards).
Time frame: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.
Time frame: Up to approximately 24 months.
PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.
Time frame: Up to approximately 24 months.
ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Time frame: Up to approximately 24 months.
Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.
Time frame: Up to approximately 24 months.