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This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7MW4911 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7MW4911 | Drug | 7MW4911 for IV infusion of various dose strengths administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and rates of adverse events | To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors | Up to approximately 2 years |
| Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D) | To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D) | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Proportion of patients whose turmor response meet the criteria of complete response or partial response | Up to approximately 2 years |
| Progression-free survival | Duration in months from treatment to disease progression or death from any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Cong | Contact | +86-18756936922 | lei.cong@mabwell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Up to approximately 2 years |
| Immunogenicity | Incidence and rates of ADA | Up to approximately 2 years |
| Tmax | Time to maximum concentration of 7MW4911 in blood | Up to 3 months |
| Cmax | Maximum concentration of 7MW4911 in bloood | Up to 3 months |
| t1/2 | Time to decrease of 7MW4911 concentration by 50% in blood | Up to 3 months |
| Area under the curve | Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) | Up to 3 months |