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This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Corhort A | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Triple-negative breast cancer (TNBC) patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Experimental: Corhort B | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. HR-positive breast cancer with HER2-Zero-expression and HER2-Low-expression patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Experimental: Corhort C | Experimental | YL202 is provided as the lyophilized powder, 200 mg/vial. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC (excluding HER2+ patients, ie, HER2 IHC 3+ or IHC 2+/ISH+ patients) will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL202 should be intravenously infused | Drug | For each patient, YL202 should be intravenously infused over 60±10 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed according to RECIST v1.1 | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | By the end of trial date, approximately within 36 months |
| Determination of the recommended dose of YL202 in the pivotal clinical study | By the end of trial date, approximately within 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed according to RECIST v1.1 | By the end of trial date, approximately within 36 months | |
| Clinical benefit rate (CBR) assessed based on RECIST v1.1 | By the end of trial date, approximately within 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| r | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 250117 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Depth of response (DpR) assessed based on RECIST v1.1 | By the end of trial date, approximately within 36 months |
| Disease control rate (DCR) assessed based on RECIST v1.1 | By the end of trial date, approximately within 36 months |
| Duration of response (DOR) assessed based on RECIST v1.1 | By the end of trial date, approximately within 36 months |
| Time to response (TTR) assessed based on RECIST v1.1 | By the end of trial date, approximately within 36 months |
| Evaluate the overall survival (OS) | By the end of trial date, approximately within 36 months |
| Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment | Approximately within 36 months |
| Characterize the PK parameter AUC | steady-state area under curve (AUC) | Approximately within 36 months |
| Characterize the PK parameter Cmax | peak concentration (Cmax) | Approximately within 36 months |
| Characterize the PK parameter Ctrough | trough concentration (Ctrough) | Approximately within 36 months |
| Characterize the PK parameter CL | clearance (CL) | Approximately within 36 months |
| Characterize the PK parameter Vd | volume of distribution (Vd) | Approximately within 36 months |
| Characterize the PK parameter t1/2 | half-life (t1/2) | Approximately within 36 months |
| Incidence of anti-YL202 antibody | Approximately within 36 months |
| Evaluate the corelaton between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate | Approximately within 36 months |
| D017437 |
| Skin and Connective Tissue Diseases |