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| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
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To investigate the safety and tolerability of a 28 day course of intravenous (IV) MG1102 in patients with solid tumors for which no standard therapy is available.
This is an open-label, Dose Escalation Study, multicenter phase I study to evaluate the safety and tolerability, determine the pharmacokinetics, and obtain preliminary information regarding pharmacodynamics and efficacy of MG1102 in subjects with solid tumor.
Each subject will receive on dose of MG1102 followed by a 6-day rest period. If the initial dose is tolerated, subject will continue with the 21 days of MG1102 administration (5 days on treatment, 2 days off treatment for 3 weeks.) Subjects that have a tumor response as stable disease, may continue therapy on a compassionate use.
Study Duration : for a minimum of 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Greenstatin | Experimental | Cohort 1 : 6 mg/m2 Cohort 2 : 12 mg/m2 Cohort 3 : 24 mg/m2 Cohort 4 : 48 mg/m2 Cohort 5 : 96 mg/m2 Cohort 6 : 192 mg/m2 28 Day Course Subjects will receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) by IV administration on Day 0. If no DLTs are observed during the 6 days following the initial infusion, the same dose will be administered once daily for 5 consecutive days followed by a 2-day rest period three times (over 21 days), completing the course on Day 27. Additional 21 Day Courses In the absence of a DLT, and in the case of stable disease or better, a subject may continue to receive MG1102 (Recombinant human apolipoprotein(a) Kringle V ) on a compassionate use basis at the same dose and regimen . |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human apolipoprotein(a) Kringle V | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability IV MG1102 | Adverse events, physical examinations, vital signs, ECGs, clinical laboratory evaluations, lipid profiles | A minimum of 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Each subject's serum drug concentration-time data to determine the pharmacokinetic profile of MG1102 | for 25 days | |
| standard clinical serum tumor markers via serum samples to obtain preliminary information regarding the pharmacodynamics of MG1102 | A minimum of 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| hyunchul chung, dr | Yonsei Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center, Yonsei University Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
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| Determination of response assessed by RECIST v1.1 and Choi criteria to obtain preliminary information regarding the efficacy of MG1102 | A minimum of 11 weeks |