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This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7MW4911 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7MW4911 | Drug | study drug |
|
| 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 |
| MTD, RED, and 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 |
|---|---|---|
| Tmax of 7MW4911 | time to maximum concentration of 7MW4911 in blood | up to 3 months |
| Cmax of 7MW4911 | maximum concentration of 7MW4911 in bloood |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker for efficacy | To explore the relationship between the expression of CDH17 in tumor tissues and other biomarkers and the efficacy and safety of 7MW4911 in patients with advanced colorectal cancer and selected gastrointestinal tumor types | Up to approximately 2 years |
Inclusion Criteria:
Exclusion Criteria:
Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
Active, untreated or symptomatic CNS metastasis
Effusions that require frequent drainage
Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
Severe respiratory disease that required hospitalization in the last 28 days.
Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
Poorly controlled blood glucose with fasting blood glucose above 10mmol/L
Recipient of allogeneic stem cell transplant or organ transplant
Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
Prohibited treatment and treatment that requires washout period
Known hypersensitivity to 7MW4911 or components of the formulation
Abuse of narcotic or psychoactive drugs
Pregnant or breastfeeding women
Other circumstances or conditions where the investigator judges to be unsuitable for study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaona Cai | Contact | +86-021-58332260 | shaona.cai@mabwell.com | |
| Wenhui Zhang | Contact | wenhui.zhang@mabwell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates of the Treasure Coast | Recruiting | Port Saint Lucie | Florida | 34952 | United States |
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| up to 3 months |
| Half life of 7MW4911 | time to decrease of 7MW4911 concentration by 50% in blood | up to 3 months |
| Area under the curve of 7MW4911 | Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) | up to 3 months |
| 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 enrollment to first disease progression | up to approximately 2 years |
| Immunogenicity of 7MW4911 | Incidence and rates of ADA | Up to approximately 2 years |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| START | Recruiting | Long Island City | New York | 11042 | United States |
|
| START Moutain Region | Recruiting | West Valley City | Utah | 84119 | United States |
|
| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|