Clinical Trial

Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

Active, Not Recruiting Phase 1/2
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Summary
This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study. It aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6045 in patients with HER2-positive, expressing, or mutated advanced solid tumors.
Trial Details
NCT Number NCT07122063
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Advanced Solid Tumors
Enrollment 266 participants
Start Date 2025-08-11
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-14