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This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.
Part 1 ( single dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. 3 dose level (3 × 10^11 Vp, 1 × 10^12 Vp, 3 × 10^12 Vp) will be evaluated.
Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SynOV1.1 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SynOV1.1 | Biological | SynOV1.1 will be administered intratumorally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The dose-limiting toxicities (DLTs) of SynOV1.1 in patients with HCC | Incidence and nature of DLT of SynOV1.1 in in patients with HCC, graded according to NCI CTCAE v5 | 30 months |
| The maximum-tolerated dose (MTD) of SynOV1.1 in patients with HCC | MTD for patients with HCC received SynOV1.1 treatment. | 30 months |
| The response rate of patients with HCC receiving SynOV1.1 | response rate based on RECIST ver. 1.1 | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| The biodistribution of SynOV1.1,as determined by the concentration of SynOV1.1 in blood of participating patients. | The concentration of SynOV1.1 in blood of participating patients will be measured by QT-PCR. | 30 months |
| The immunogenicity of SynOV1.1, as determined by quantitation of neutralizing antibodies in blood of participating patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ren, Bachelor | Contact | 17390905515 | y.ren@syngen.tech | |
| Shuguang Peng, Master | Contact | 86+18810456513 | sg.peng@syngen.tech |
| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | The First Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130012 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The quantitation of neutralizing antibodies in blood of participating patients will be measured by CPE. |
| 30 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Determine the number of participants who received SynOV1.1 in combination with Atezolizumab treatment with treatment-related adverse events, as assessed by the CTCAE v5.0 | 30 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |