A PHASE 1, OPEN LABEL, DOSE ESCALATION STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MG1102 IN PATIENTS WITH SOLID TUMORS
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
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
hyunchul chung, dr
Yonsei Cancer Center
United States: Food and Drug Administration