drugset / Trial / NCT06775236
Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Phase 2 aims to assess the efficacy and safety of SYS6010 monotherapy or in combination with SYH2051 compared to investigator-selected chemotherapy in patients with EGFR-expressing, unresectable locally advanced or metastatic advanced breast cancer.
Timeline
- Start
- 2025-03-20
- Primary completion
- 2027-06-15
- Completion
- 2028-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | — | — |
| Comparator | Eribulin | Small molecule | — | — |
| Comparator | Gemcitabine | Small molecule | — | — |
| Subject | SYH2051 | Unknown | 40 mg | Oral |
| Subject | SYH2051 | Unknown | 60 mg | Oral |
| Subject | SYH2051 | Unknown | 80 mg | Oral |
| Subject | SYS6010 | Monoclonal antibody | 3.2 mg/kg | Intravenous |
| Subject | SYS6010 | Monoclonal antibody | 3.6 mg/kg | Intravenous |
| Comparator | Vinorelbine | Small molecule | — | — |