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This study is a Phase 1/2, 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Up to 28 days post last drug administration | |
| Objective Response Rate (Phase 2) | Defined as the percentage of subjects who experience a best response of either CR or PR. CR and PR must be confirmed ≥ 28 days later. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Maximum observed concentration (Cmax) | 24 months |
| Pharmacokinetic parameter for 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 |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40288679 | Derived | Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25. |
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Area under the concentration-time curve (AUC) |
| 24 months |
| Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Half-life (t1/2) | 24 months |
| Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE) | Clearance (CL) | 24 months |
| Disease Control Rate | Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD) | Up to 24 months |
| Duration of Response | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR. | Up to 24 months |
| Time to Response | Time from the date of first infusion to the date of confirmed CR or PR | Up to 24 months |
| Progression Free Survival | Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause | Up to 24 months |
| Overall Survival | Time from the date of first infusion until the date of death from any cause. | Up to 24 months |
| Incidence of Anti-Drug Antibody (ADA) | Up to 24 months |