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To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort | Experimental | 9MW2821+ other anti-cancer therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821+other anticancer therapy | Drug | Subjects will receive intravenous (IV) infusion of 9MW2821 +other anticancer therapy as per protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DoR | Duration of Response | Up to 24 months |
| TTR | Time to Response | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanmei Lou, Professor | Contact | 13355783145 | louhm@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hanmei Lou, Professor | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| DCR | Disease Control Rate | Up to 24 months |
| PFS | Progression Free Survival | Up to 24 months |
| OS | Overall Survival | 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 | 24 months |