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An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
Details
| Lead sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 150 |
| Start date | 2025-03-18 |
| Completion | 2026-07 |
Conditions
- Ovarian Cancer
Interventions
- SHR-A1811
- Carboplatin
- Bevacizumab
- Oxaliplatin for Injection
- Paclitaxel injection
- Doxorubicin hydrochloride liposome injection
- Adebrelimab Injection
Primary outcomes
- Dose limited toxicity (DLT) — Up to 21 days.
- Recommended phase II dose (RP2D) — Up to 21 days.
- Objective response rate (ORR) — Every 9 weeks lasting about one year.
Countries
China