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This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.
The study consists of dose escalation and dose expansion, the dose escalation will be performed in a standard 3+3 manner at the dose of 0.1mg/kg、0.5mg/kg、1 mg/kg、1.5mg/kg、2 mg/kg、2.5mg/kg and 3 mg/kg, and the dose expansion will be done in specific tumor types. Patients enrolled in the study will receive SG2918 treatment every three weeks (Q3W), until disease progression, intolerable toxicity or others, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SG2918 | Experimental | SG2918 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SG2918 | Drug | The SG2918 will be administrated by intravenous infusion every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 5.0 | From the time of first dose until 30 days after last dose of SG2918 |
| Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) | DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as related to study drug, and unrelated to disease, disease progression, intercurrent illness or concomitant medications that occurs within the first cycle (three weeks) of treatment. | Cycle 1 (up to 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics(PK): Cmax | Maximum drug concentration after administration | From the time of first dose until 30 days after last dose of SG2918 |
| Pharmacokinetics (PK): AUC | Area Under the Curve of the drug after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400000 | China | ||
| Henan Cancer Hospital |
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| From the time of first dose until 30 days after last dose of SG2918 |
| Pharmacokinetics (PK): T1/2 | Elimination half-life of the drug after administration | From the time of first dose until 30 days after last dose of SG2918 |
| Pharmacokinetics (PK): CL | Clearance of the drug after administration | From the time of first dose until 30 days after last dose of SG2918 |
| Pharmacodynamic(PD): cellular biomarkers | cellular biomarkers including CD4+ T cells, CD8+ T cells, Myeloid-derived suppressor cells (MDSCs) and Regulatory T cells (Tregs) | From the time of first dose until 30 days after last dose of SG2918 |
| Pharmacodynamic(PD): cytokine levels | Peripheral blood cytokine levels including measurements for TNF-α,IFN-γ,IL-2,IL-4、IL-6,IL-8,IL-10,IL-1β | From the time of first dose until 30 days after last dose of SG2918 |
| Immunogenicity endpoints | Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples) | Through study completion, an average of one year,assessed up to approximately 12 months |
| Efficacy endpoints | objective response rate (ORR) | Through study completion, an average of one year,assessed up to approximately 12 months |
| Zhengzhou |
| Henan |
| 450003 |
| China |
| Hunan Cancer Hospital | Changsha | Hunan | 410031 | China |
| Shanghai first maternity and infant hospital | Shanghai | Shanghai Municipality | 200126 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 30013 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310005 | China |