A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors

This trial is a multicenter, open-label, dose exploration and cohort expansion Phase II clinical study designed to evaluate the safety, immunogenicity, and preliminary efficacy of different dosing regimens of SYS6026 injection (hereinafter referred to as "SYS6026") combined with Enlonstobart in patients with unresectable locally advanced or metastatic solid tumors associated with HPV types 16 or 18. The study consists of two phases: dose exploration and cohort expansion.

NCT Number	NCT07684261
Lead Sponsor	CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions	Solid Tumor
Enrollment	186 participants
Start Date	2026-07-20
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-06