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This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW2821 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW2821 | Drug | All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15). |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 28 days post last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37196158 | Derived | Zhou W, Fang P, Yu D, Ren H, You M, Yin L, Mei F, Zhu H, Wang Z, Xu H, Cao Y, Sun X, Xu X, Bi J, Wang J, Ma L, Wang X, Chen L, Zhang Y, Cen X, Zhu X, Lou L, Liu D, Tan X, Yang J, Meng T, Shen J. Preclinical Evaluation of 9MW2821, a Site-Specific Monomethyl Auristatin E-based Antibody-Drug Conjugate for Treatment of Nectin-4-expressing Cancers. Mol Cancer Ther. 2023 Aug 1;22(8):913-925. doi: 10.1158/1535-7163.MCT-22-0743. |
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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 |
| Objective Response Rate | ORR | Up to 24 months |
| Disease Control Rate | DCR | Up to 24 months |
| Duration of Response | DoR | Up to 24 months |
| Time to Response | TTR | Up to 24 months |
| Progression Free Survival | PFS | Up to 24 months |
| Overall Survival | OS | Up to 24 months |
| Incidence of Anti-Drug Antibody (ADA) | ADA | Up to 24 months |
| Beijing University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
|