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A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Details
| Lead sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 270 |
| Start date | 2023-10 |
| Completion | 2025-12 |
Conditions
- Advanced Solid Tumors
Interventions
- SHR-A2009 for injection ； Almonertinib Mesilate Tablets
- SHR-A2009 for injection；Adebrelimab Injection
Primary outcomes
- Incidence of dose-limiting toxicity (DLT) (phase IB) — 21 days after the first dose was administered to each subject.
- Objective Response Rate (ORR) (phase II). — 2 years