drugset
drugset / Trial / NCT07415863

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

NCT07415863 ↗

Phase 1/2 Recruiting 820 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-30
Primary completion
2027-12-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SYS6043 Other / unclassified — Subcutaneous

Indications

No indication recorded.