This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Subjects with gynaecological malignancies
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGObjective response rate (ORR)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Duration of response (DOR)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Incidence and severity of adverse events (AEs)
Time frame: From Day 1 to 90 days after last dose
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