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This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.
The study was divided into two phases: dose escalation and dose expansion
The study was divided into two phases: dose escalation and dose expansion Detailed Description: This trial is a multi-center, open-label investigator-initiated clinical study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WTX212A | Experimental | WTX212A infusion once every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WTX212A | Drug | WTX212A infusion once every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | The incidence of Adverse Events during the treatment of WTX212A injection | through study completion, an average of 1 year |
| incidence of treatment related adverse events (TRAE) | The incidence of TRAE during the treatment of WTX212A injection | through study completion, an average of 1 year |
| incidence of severe adverse events (SAE) | The incidence of SAE during the treatment of WTX212A injection | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax | through study completion, an average of 1 months |
| Tmax | Tmax | through study completion, an average of 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug antibodies (ADA) | The proportion of anti-drug antibodies (ADA) after WTX212A infusion | through study completion, an average of 1 year |
| The absolute value of immune cell subsets | The absolute value of immune cell subsets |
Inclusion Criteria:
Exclusion Criteria:
- 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. History of adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
6. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qi Zhang, M.D. | Contact | 13858108798 | qi.zhang@zju.edu.cn | |
| Qihan Fu, M.D. | Contact | ayfuqihan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| AUC0-t | AUC0-t | through study completion, an average of 1 months |
| t1/2 | t1/2 | through study completion, an average of 1 months |
| CL | CL | through study completion, an average of 1 months |
| Cmin,ss | Cmin,ss | through study completion, an average of 1 months |
| Cmax,ss | Cmax,ss | through study completion, an average of 1 months |
| Tmax,ss | Tmax,ss | through study completion, an average of 1 months |
| AUC(0-τ)ss. | AUC(0-τ)ss. | through study completion, an average of 1 months |
| the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells | the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion | through study completion, an average of 1 year |
| Objecive Response Rate (ORR) | According to Response Evaluation Criteria In Solid Tumors Version 1.1 | through study completion, an average of 4 months |
| Anti-drug antibody (ADA) | escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA | through study completion, an average of 1 year |
| through study completion, an average of 1 year |
| The percentage of immune cell subsets | The percentage of immune cell subsets | through study completion, an average of 1 year |
| The proportion of PD-L1 expression in tumor cells/immune cells | The proportion of PD-L1 expression in tumor cells/immune cells | through study completion, an average of 1 year |