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This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M2ES 7.5mg | Experimental | M2ES 7.5mg |
|
| M2ES 15mg | Experimental | M2ES 15mg |
|
| M2ES 30mg | Experimental | M2ES 30mg |
|
| M2ES 60mg | Experimental | M2ES 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M2ES 7.5mg | Drug | M2ES 7.5mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerate dosage | The maxium tolerate dosage | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) behavior of M2ES in tumor subject | Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors | 4 week |
| The incidence rate of adverse event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Su LI, PhD | Contact | 8620-87343571 | lisusu@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, master | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| M2ES 15mg | Drug | M2ES 15mg |
|
|
| M2ES 30mg | Drug | M2ES 30mg |
|
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| M2ES 60mg | Drug | M2ES 60mg |
|
|
The incidence rate of adverse event
| 4 weeks |