A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy

Sponsor
Green Cross Corporation
Study ID
NCT03454620
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan — DRUG
    GC1118 combination with irinotecan
  • FOLFIRI — DRUG
    GC1118 combination with FOLFIRI

Study Details

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)

Key Dates

Start date
Apr 2, 2018
Status verified
Mar 2022
Primary completion
Sep 17, 2021
Completion
Jan 10, 2022

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GC1118 combination with irinotecan
    GC1118 weekly(3mg or 4mg) + irinotecan 180mg/m2 biweekly dosing
  • Experimental: GC1118 combination with FOLFIRI
    GC1118 weekly(3mg or 4mg) + FOLFIRI biweekly dosing

Primary Outcome Measure

Dose Limited Toxicity (DLT) [ Time Frame: through study completion, approximately 5 months ]

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