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

A Multicenter, Open-Label Phase I/II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial consists of two parts:Phase I (dose-escalation study): divided into two segments:Dose-escalation phase and PK expansion phase Phase II (dose-expansion study)

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SYS6045	SYS6045, IV Q3W

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-07-30
• Completion: 2027-07-30
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: China