Spots Global Cancer Trial Database for A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy
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Trial Identification
Brief Title: A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy
Official Title: Phase 1b/2a Study of GC1118 in Combination With Irinotecan or FOLFIRI in Patients With Recurrent/Metastatic Solid Tumor
Study ID: NCT03454620
Study Description
Brief Summary: The purpose of the study is to assess the safety and tolerability of GC1118 in combination with irinotecan or FOLFIRI in order to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D)
Detailed Description: A Phse 1b/2a, dose-finding, open-label, prospective study This study consists of the Phase 1b part designed to determine the MTD and RP2D of GC1118 when administered in combination with irinotecan or FOLFIRI to patients with recurrent metastatic solid tumors and the Phase 2a part designed to assess the efficacy of GC1118 in combination with FOLFIRI as second-line therapy for recurrent/metastatic colorectal cancer
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chonnam National University Hwasun Hospital, Chŏnam, , Korea, Republic of
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Seoul Asan Medical Center, Seoul, , Korea, Republic of
Seoul National Universtiy Hosipital, Seoul, , Korea, Republic of
Yonsei University Health Care System, Seoul, , Korea, Republic of
Contact Details
Name: Yung Jue Bang, M.D.,Ph.D.
Affiliation: Seoul National University Hosipital
Role: PRINCIPAL_INVESTIGATOR
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