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SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

StatusRecruiting
PhasePhase 3
Started2024-05-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 9, 2024 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-08-08
Not Yet Recruiting→Recruiting Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-05-31→confirmed 2024-05-10
Primary endpoints1 entry, revised
Progression-free Survival (PFS) assessed by siteBlinded investigatorIndepend Review Committee (BIRC) as per RECIST 1.1
Study sitesdetails revised at 2 of 2 sites
2024-04-27
Original filing
This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
Trial Details
NCT Number NCT06394492
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Ovarian Cancer
Enrollment 440 participants
Start Date 2024-05-10
Primary Completion 2026-05-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-09