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.
1. Able to understand and voluntarily sign the written informed consent form (ICF);
2. Male or female subjects aged over 18 years old (inclusive).
3. Patients with solid tumor who have unresectable locally advanced or metastatic disease;
4. At least one measurable lesion, as defined by RECIST 1.1 criteria;
1. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;
2. Patients with a history of autoimmune diseases;
3. Presence of active infection (e.g., subjects are receiving anti-infection therapy);
4. Severe or uncontrolled cardiovascular disorder requiring treatment;
Parallel
SYS6006
Biological/VaccineDrug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
Enlonstobart
Biological/VaccineEnlonstobart IV
Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)
Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .
Phase Ib:Incidence and frequency of serious adverse events (SAEs)
Phase Ib:Maximum tolerated dose (MTD)
Disease control rate (DCR) per RECIST 1.1
Duration of response (DoR) per RECIST 1.1
Progression free survival (PFS) per RECIST 1.1
Time to response(TTR)
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