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| Name | Class |
|---|---|
| Westlake Therapeutics | INDUSTRY |
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This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors.
This is a single-arm, open-label, investigator-initiated clinical study (IIT) designed to evaluate the preliminary efficacy, safety, tolerability, immunogenicity, and pharmacokinetic (PK) characteristics of WTX212A Injection in patients with advanced solid tumors. The study is divided into two phases: an initial exploratory phase and an expansion phase. The study includes two cohorts: Cohort A (WTX212A monotherapy) and Cohort B (WTX212A in combination with radiotherapy)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort A | Experimental | Experimental: Cohort A Intervention: Drug: WTX212A Monotherapy |
|
| Experimental: Cohort B | Experimental | Experimental: Cohort B Intervention: Drug: WTX212A+Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WTX212A injection | Drug | Erythrocyte-αPD-1 Antibody Conjugates |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy | Objective Response Rate (ORR) of WTX212A monotherapy or WTX212A in combination with radiotherapy | From enrollment to the end of treatment,an average of 1 year |
| Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy | Disease Control Rate (DCR) of WTX212A monotherapy or WTX212A in combination with radiotherapy | From enrollment to the end of treatment,an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of WTX212A monotherapy or WTX212A in combination with radiotherapy | Progression-Free Survival (PFS).etc of WTX212A monotherapy or WTX212A in combination with radiotherapy, as evaluated using the Evaluation Criteria in Solid Tumors (Version 1.1). | Every 6 weeks until the end of the last treatment ,an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Biomarkers Relevant to the Study(T-Cell) | Assess the percentages of immune cell subsets (T-Cell ) before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers | Through study completion, an average of 1 year |
| Assess Biomarkers Relevant to the Study(MDSC) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RuiHua Xu, PhD | Contact | 020-87343468 | xurh@sysucc.org.cn | |
| Huiyan Luo, PhD | Contact | 86-20-87343804 | Luohy@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| RuiHua Xu, PhD | Cancer Center of SUN YAT-senU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of SUN YAT-senU | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Number of Cohort : 2
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No Masking
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| radiotherapy | Radiation | Radiotherapy will be administered sequentially, with WTX212A treatment starting within one week after the completion of radiotherapy |
|
| Safety of WTX212A monotherapy or WTX212A in combination with radiotherapy |
Incidence of adverse events (AEs), treatment-related AEs, and serious adverse events (SAEs) of WTX212A monotherapy or WTX212A in combination with radiotherapy. |
| From the first treatment to the end of the safety visit,an average of 1 year |
| Pharmacokinetic characteristics(Cmax) | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Cmax | Through study completion, an average of 1 year |
| Pharmacokinetic characteristics(Tmax) | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to Tmax | Through study completion, an average of 1 year |
| Pharmacokinetic characteristics(AUC0-t) | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to AUC0-t | Through study completion, an average of 1 year |
| Pharmacokinetic characteristics(t1/2) | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to t1/2 | Through study completion, an average of 1 year |
| Pharmacokinetic characteristics(CL) | Pharmacokinetic parameters of peripheral blood in subjects after administration, including but not limited to CL | Through study completion, an average of 1 year |
| Number of Anti-drug antibody (ADA) | Describe the number 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 |
| Percentage of Anti-drug antibody (ADA) | Describe the 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 |
Assess the percentages of MDSC before and after treatment for advanced malignant tumors, changes in immunophenotyping and other meaningful Biomarkers |
| Through study completion, an average of 1 year |
| Cancer center of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |