Spots Global Cancer Trial Database for Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
Official Title: A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT03478995
Interventions
Study Description
Brief Summary: Patients will be enrolled in two stages: * Dose-escalation stage: Approximately 15-30 patients will be enrolled. * Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.
Detailed Description: * Dose-escalation stage : designed as classical 3+3 to determine MTD or RP2D to evaluate approximately GX-I7. * Dose-expansion stage : designed to enroll additional 6-12 patients to acquire additional safety and pharmacodynamic data to more fully inform the dose selection for RP2D
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, of the Catholic University, Seoul, , Korea, Republic of
Contact Details
Name: Joo Hyuk Sohn, MD
Affiliation: Yonsei University Health System, Severance Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Tae Won Kim, MD
Affiliation: Medical Oncology, Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Myoung-Ah Lee, MD
Affiliation: Medical Oncology, Seoul St. Mary's Hospital, of the Catholic University
Role: PRINCIPAL_INVESTIGATOR
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