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)
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
GC1118 combination with irinotecan
GC1118 combination with FOLFIRI
National Cancer Center
Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Jeonam, South Korea
Seoul Asan Medical Center
Seoul, South Korea
Dose Limited Toxicity (DLT)
Profile of DLT
Time frame: through study completion, approximately 5 months
Tumor response according to RECIST 1.1 criteria
best overall response (BOR)
Time frame: before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
Tumor response according to RECIST 1.1 criteria
objective response rate (ORR)
Time frame: before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
Pharmacokinetics of GC1118
area under th curve (AUC)
Time frame: through study completion, approximately 5 months
Pharmacokinetics of GC1118
half life
Time frame: through study completion, approximately 5 months
Pharmacokinetics of GC1118
clearance
Time frame: through study completion, approximately 5 months
Pharmacokinetics of GC1118
peak serum concentration (Cmax)
Time frame: through study completion, approximately 5 months
Immunogenicity of GC1118
occurrence frequency of anti-drug antibody
Time frame: every odd number cycles through treatment period, 28 days after the last treatment
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Seoul National Universtiy Hosipital
Seoul, South Korea
Yonsei University Health Care System
Seoul, South Korea