Clinical Trial

Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors

Recruiting Phase 1/2
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Summary
Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.
Trial Details
NCT Number NCT07415863
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Advanced/Metastatic Solid Tumors
Enrollment 820 participants
Start Date 2024-12-30
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-17