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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6006 + Enlonstobart | Experimental | Phase Ib Dose Escalation Cohort Dose level 1 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart. Dose level 2 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.
Phase II Investigational Treatment:The maximum safe dose of SYS6006 in combination Enlonstobart (as determined in the phase Ib cohort). |
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| Enlonstobart | Active Comparator | Phase II Investigational Treatment:Enlonstobart Intravenous infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6006 | Biological | Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase) | Within 21 days after the start of the treatment | |
| Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) . | Through study completion, an average of l year | |
| Phase Ib:Incidence and frequency of serious adverse events (SAEs) | Through study completion, an average of l year | |
| Phase Ib:Maximum tolerated dose (MTD) | Every 21 days while on treatment (estimated 6 months) | |
| Phase Ib: Recommended Phase II dose (RP2D) | Every 21 days while on treatment (estimated 6 months) | |
| Phase II: ORR as assessed by the investigator according to RECIST v1.1 | through study completion, an average of 1year. | |
| Phase II: Incidence and frequency of TEAEs. | through study completion, an average of l year | |
| Phase II:Incidence and frequency of SAEs. | through study completion, an average of l year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) per RECIST 1.1 | Up to approximately 24 months after the first participant is enrolled | |
| Duration of response (DoR) per RECIST 1.1 | Up to approximately 24 months after the first participant is enrolled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| C000722716 | SYS6006 COVID-19 vaccine |
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| Enlonstobart | Biological | Enlonstobart IV |
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| Progression free survival (PFS) per RECIST 1.1 | Up to approximately 24months after the first participant is enrolled |
| Time to response(TTR) | Up to approximately 24months after the first participant is enrolled |
| Overall survival(OS) | Up to approximately 24 months after the first participant is enrolled |
| Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0) | Up to approximately 24 months after the first participant is enrolled |
| PK parameters: The plasma concentration of enlonstobart | Up to approximately 24 months after the first participant is enrolled |
| Correlation between PD-L1 expression level (measured as Tumor Proportion Score [TPS] by 22C3 IHC assay) and objective response rate (ORR, as assessed by RECIST 1.1 criteria) | Up to approximately 24 months after the first participant is enrolled |
| To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells | through study completion, an average of l year |