Clinical Trial

Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors

Not Yet Recruiting Phase 1/2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-09.
Trial Details
NCT Number NCT06775236
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Advanced Solid Tumors, Breast Cancer
Enrollment 410 participants
Start Date 2025-03-20
Primary Completion 2027-06-15 (estimated)
Study Completion 2028-01-15 (estimated)
Updated on ClinicalTrials.gov 2025-03-19