NCT06958679

Evaluation of SYS6005 in Patients With Advanced Malignant Tumor

A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Immunogenicity, and Preliminary Anti-tumor Activity of SYS6005 in Patients With Advanced Malignant Tumor

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase I, open-label, multicenter study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6005 in advanced malignancies, comprising dose-escalation and expansion phases. The escalation phase employs a BOIN design with accelerated titration across seven dose levels, featuring a 21-day DLT observation period in Cycle 1, with dose adjustments guided by a Safety Monitoring Committee. In the expansion phase, one or more dosing regimens and tumor types will be selected, and participants will receive SYS6005 R2PD for further exploration and validation. Treatment continues until disease progression, unacceptable toxicity, or other discontinuation criteria. Safety monitoring includes AEs, labs, and ECOG PS, while efficacy is assessed via imaging. PK and immunogenicity samples are collected, and survival is tracked quarterly until death or study end. The study aims to determine the maximum tolerance dose (MTD)/recommended phase 2 dose (RP2D) and characterize SYS6005's clinical profile.

Conditions

• B-cell Malignancies
• Solid Tumors

Interventions

Type	Name	Description
DRUG	SYS6005	SYS6005 administered via IV infusion on , Day 1 of each 21-day cycle

Timeline

• Start date: 2025-04-03
• Primary completion: 2027-01-30
• Completion: 2028-06-30
• First posted: 2025-05-06
• Last updated: 2025-05-14

Locations

1 site across 1 country: China