This trial is a randomized, open-label, positive-controlled, multicenter phase Ib/III clinical trial, divided into two phases. Phase Ib aims to evaluate the safety and tolerability of SHR-A1811 in combination with bevacizumab as first-line maintenance therapy in participants with epithelial ovarian cancer without pathological progression (PD) after first-line platinum-based doublet chemotherapy plus bevacizumab (hereinafter referred to as "platinum-based triple therapy"). Phase III aims to evaluate the efficacy and safety of SHR-A1811 in combination with bevacizumab versus bevacizumab as maintenance therapy in participants with epithelial ovarian cancer without PD after first-line platinum-based triple therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
trastuzumab
bevacizumab
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China
Yunnan Cancer Hospital
Yunnan, Kunming, China
Dose limited toxicity (DLT)
Time frame: up to 21 days
Progression Free Survival (PFS)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
AEs+SAEs
Time frame: from the first drug administration to within 40 days for the last treatment dose
Ctrough
Time frame: from the first drug administration to within 40 days for the last treatment dose
ADA
Time frame: from the first drug administration to within 40 days for the last treatment dose
Overall survival (OS)
Time frame: Approximately 3 years after last subject enrolled
Second progression-free survival (PFS2)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Objective Response Rate (ORR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Disease Control Rate (DCR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Duration of Response (DoR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to disease progression (TTP)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Cancer antigen-125 response rate (CA-125 RR)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
Time to the start of subsequent treatment (TFST)
Time frame: the first 108 weeks, every 12 weeks, then every 24 weeks, lasting about 3 years
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