drugset / Trial / NCT07122063

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

NCT07122063 ↗

Phase 1/2 Active not recruiting 266 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-11
Primary completion
2027-07-30
Completion
2027-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SYS6045 Unknown — —

Indications