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| Name | Class |
|---|---|
| Westlake Therapeutics | INDUSTRY |
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This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
The trial consist of Screening Period (30 days), Treatment Period (21*n days), Safety Follow-up Period (90 days) and Survival follow-up.
About 20 subjects are planned to be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-dose in patients with advanced lung cancer | Experimental | WTX212A injection Fixed-dose in advanced lung cancer patients |
|
| Combined Study in patients with advanced lung cancer | Experimental | Fixed-dose WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WTX212A injection | Drug | The WTX212A infusion is given every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of patients with IO- resistant advanced lung cancer. | Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| the safety of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer patients | The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of WTX212A injection | 1 year |
| To evaluate the pharmacokinetic ( PK ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacodynamics ( PD ) characteristics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO- resistant advanced lung cancer | The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion | 1 year |
| To explore and evaluate WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO- resistant advanced lung cancer before and after treatment, analysis of immune cell subpopulations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| pingli wang, phD | Contact | (0571)87783520 | pingliwang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| pingli wang, phD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
There are no plans to disclose the data
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Single-center, open-label, exploratory study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with advanced lung cancer
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| PD -1/PD-L1 monoclonal antibody | Drug | The PD -1/PD-L1 monoclonal antibody is given every 21 days |
|
|
Peak Plasma Concentration (Cmax) |
| 1 year |
| To evaluate the immunogenicity of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in patients with IO -resistant advanced lung cancercheckpoint inhibitor resistance in advanced lung cancer patients | Describe the percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment | 1 year |
Calculate the absolute values and percentages of immune cell subpopulations (absolute values and percentages of effector cells and immunosuppressive cells) before and after treatment of WTX212A injection combined with PD -1/PD-L1 monoclonal antibody in the treatment of IO -resistant advanced lung cancer. Immunomic analysis Variety |
| 1 year |
| To explore and evaluate the changes in spleen size in patients with IO- resistant advanced lung cancer before and after treatment with WTX212A injection combined with PD -1/PD-L1 monoclonal antibody | Changes in spleen size before and after treatmen | 1 year |