Spots Global Cancer Trial Database for Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
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Trial Identification
Brief Title: Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma
Official Title: A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma
Study ID: NCT03619239
Conditions
Interventions
Study Description
Brief Summary: Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 12-24 patients will be enrolled.
Detailed Description: Detailed Description: • Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7 * pre-determined dose(Level I)\~ pre-determined dose(Level IV)
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Seocho, Korea, Republic of
Contact Details
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