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This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW3811 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW3811 Injection | Drug | Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) as assessed by CTCAE v5.0 | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | up to 24 weeks |
| Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0 | A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1 | Cycle 1 Day 1 to Cycle 1 Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators | To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. |
| up to 24 weeks |
| Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators | To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators | To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Maximum Plasma Concentration (Cmax) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Time to reach Cmax (Tmax) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Terminal elimination half-life (t1/2) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| AUC from time 0 extrapolated to infinity (AUC0-inf) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Terminal elimination rate constant (λz) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Apparent clearance (CL) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Volume of distribution (Vz) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors. | up to 24 weeks |
| Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline | To determine the immunogenicity of 9MW3811. | up to 24 weeks |