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A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.
Details
| Lead sponsor | Jiangsu HengRui Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 364 |
| Start date | 2023-08-11 |
| Completion | 2026-12-29 |
Conditions
- HER2-expressing Advanced Solid Tumors
Interventions
- SHR-A1811 combined with Pyrotinib.
- SHR-A1811 combined with other antitumor therapies
Primary outcomes
- Part A: Maximally Tolerated Dose (MTD),)(Phase ⅠB). — From the first dose to the last dose, about 11 months
- Part A: recommended phase 2 dose (RP2D)(Phase ⅠB). — From the first dose to the last dose, about 11 months
- Part A: Adverse Events (Phase ⅠB) — From the first dose to the last dose, about 11 months
- Part A: Objective Response Rate (ORR) (Phase Ⅱ) — From the first dose to the last dose, about 11 months
Countries
China