drugset / Trial / NCT07622225

SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors

NCT07622225

Phase 1/2 Not yet recruiting 264 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a Phase Ib/II clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.

Timeline

Start
2026-05-29
Primary completion
2028-12-31
Completion
2030-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Enlonstobart Monoclonal antibody Intravenous
Subject SYS6006 Messenger RNA (mRNA) Intramuscular

Indications