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This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.
This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 6MW3511 | Experimental | Subjects will receive 6MW3511 by intravenous administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Infusion | Drug | Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a Dose Limiting Toxicity (DLT) | DLTs will be assessed during the first 3 weeks of treatment for dose-escalation phase. | Up to Week 3 |
| Number of participants with adverse events (AEs) | Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs. | Up to 4 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | Up to 2 years |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Up to 2 years |
| Maximum observed concentration (Cmax) of 6MW3511 | The endpoints for assessment of PK of 6MW3511 include serum concentrations of 6MW3511 at different timepoints after administration. | Up to 4 weeks after last treatment |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of 6MW3511 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | Up to 4 weeks after last treatment |
| D007263 |
| Infusions, Parenteral |