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The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102 for injection | Drug | SHR-A2102 for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Assessed by Investigator according to RECIST 1.1 criteria. | Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | Assessed by Investigator according to RECIST 1.1 criteria. | Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZhiFei Lin, M.M | Contact | 18702197991 | zhifei.lin.zl3@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Assessed by Investigator according to RECIST 1.1 criteria. |
| Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. |
| Time to response (TTR) | Assessed by Investigator according to RECIST 1.1 criteria. | Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. |
| Progression free survival (PFS) | Assessed by Investigator according to RECIST 1.1 criteria. | Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months. |
| Overall survival (OS) | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. | follow up once every 60 days. Up to approximately 36 months. |
| 12 month survival rate | Survival rate within one year. | follow up once every 60 days. Up to approximately 24 months. |
| Adverse Events (AEs) | Include incidence,grade(judged according to NCI-CTCAE V5.0 standards). | Up to approximately 24 months. |
| PK traits of SHR-A2102: Plasma concentrations of SHR-A2102. | Up to approximately 24 months. |
| PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites. | Up to approximately 24 months. |
| ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. | Up to approximately 24 months. |
| Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point. | Up to approximately 24 months. |