NCT06211023

A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer

An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	SHR-1921	SHR-1921
DRUG	carboplatin	carboplatin AUC 4
DRUG	carboplatin	carboplatin AUC 5
DRUG	platinum-based doublet chemotherapy	platinum-based doublet chemotherapy

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2024-01-18
• Last updated: 2024-01-18