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This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort A:9MW2821 | Experimental | Drug:9MW2821 |
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| Treatment Cohort B:9MW2821+PD-1 inhibitior | Experimental | Drug: 9MW2821,PD-1 inhibitior |
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| Treatment Cohort C:9MW2821 ±PD-1 inhibitior | Experimental | Drug: 9MW2821,PD-1 inhibitior |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821 | Drug | Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | ORR | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | DoR | Up to 24 months |
| Time to Response | TTR | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, Professor | Contact | 13918273761 | syner2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| PD-1 inhibitior | Drug | Subjects will receive intravenous (IV) infusion of PD-1 inhibitor as per protocol |
|
| Disease Control Rate | DCR | Up to 24 months |
| Progression Free Survival | PFS | Up to 24 months |
| Overall Survival | OS | Up to 24 months |
| Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Maximum observed concentration (Cmax) | 24 months |
| Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Area under the concentration-time curve (AUC) | 24 months |
| Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Half-life (t1/2) | 24 months |
| Pharmacokinetic parameter:total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Clearance (CL) | 24 months |
| Incidence of Anti-Drug Antibody (ADA) | ADA | Up to 24 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |