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This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Cohort | Experimental | Subjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol |
|
| Single agent Cohort | Experimental | Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol |
|
| 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 |
|---|---|---|
| Incidence of AE/SAE (phase Ib) | Adverse event (AE), serious adverse event (SAE) | Up to approximately 24 months |
| Objective Response Rate, ORR (phase II) | The proportion of participants with complete response (CR) or partial response (PR) | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response, DOR | Time from the date of the first CR or PR to the earliest date of disease progression or death | Up to approximately 24 months |
| Time To Response, TTR | Time from the date of first infusion to the date of CR or PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang | Contact | 13938244776 | fengw010@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 451161 | China |
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| Other anti-cancer therapy | Drug | Subjects will receive other anticancer therapy as per protocol |
|
| Up to approximately 24 months |
| Disease Control Rate, DCR | The percentage of subjects who experience CR, PR or stable disease (SD) | Up to approximately 24 months |
| Progression-Free Survival, PFS | Time from the date of first infusion to the earliest date of disease progression or death | Up to approximately 24 months |
| Overall Survival, OS | Time from the date of first infusion to the date of death | Up to approximately 24 months |
| Pharmacokinetics parameter, Tmax | Peak time | Up to approximately 24 months |
| Pharmacokinetics parameter, Cmax | Maximum concentration | Up to approximately 24 months |
| Pharmacokinetics parameter, AUC | Area under the concentration-time curve | Up to approximately 24 months |
| Pharmacokinetics parameter, t1/2 | Half-life | Up to approximately 24 months |
| Pharmacokinetics parameter, V | Apparent volume of distribution | Up to approximately 24 months |
| Pharmacokinetics parameter, CL | Clearance | Up to approximately 24 months |
| Immunogenicity parameter | Anti-Drug Antibody (ADA) of 9MW2821 | Up to approximately 24 months |