Advanced Solid Tumors
Conditions
Brief 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.
Interventions
BIOLOGICALSYS6006
Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection
BIOLOGICALEnlonstobart
Enlonstobart IV
Sponsors
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * 5\. ECOG performance status of 0-2; * 6\. Expected survival ≥ 3 months; * 7\. Adequate function of major organs and bone marrow; * 8\. Women or man of childbearing potential must use highly effective contraception.
Exclusion 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; * 5\. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed