SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2035

Conditions
Ovarian Cancer
Interventions
DRUG

SHR-A1811

"Injection SHR - A1811 (hereinafter referred to as SHR - A1811) is an antibody - drug conjugate (ADC) targeting the HER2 protein, independently developed by Suzhou Shengdeya Biopharmaceutical Co., Ltd. (hereinafter referred to as the sponsor). It is composed of a recombinant humanized anti - HER2 IgG1 monoclonal antibody (SHR - 1805) conjugated with a small molecule component, SHR169106."

DRUG

Chemotherapy

"The treatment regimens for the control group are as follows:~Liposomal doxorubicin: Administered intravenously on Day 1 of each 4 - week treatment cycle at a dose of 40 mg/m².~Paclitaxel: Given intravenously on Days 1, 8, 15, and 22 of each 4 - week treatment cycle at a dose of 80 mg/m² per administration.~Topotecan: Intravenously infused on Days 1, 8, and 15 of each 4 - week treatment cycle at a daily dose of 4 mg/m².~Gemcitabine: Infused intravenously on Days 1 and 8 of each 3 - week treatment cycle at a daily dose of 1000 mg/m²."

Trial Locations (1)

430030

Tongji Hospital, Wuhan

All Listed Sponsors
lead

Tongji Hospital

OTHER