NCT07110883

A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.

Detailed description

This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors. The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6023 in participants with advanced solid tumors. The eligible subjects will receive intravenous infusion of SYS6023 on the first day of each cycle, with each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of a new anti-tumor treatment, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	SYS6023	SYS6023 is a novel antibody-drug conjugate (ADC) targeting HER3, administered via intravenous infusion.

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-10-31
• Completion: 2028-10-31
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

2 sites across 1 country: China