Trials / Completed
CompletedNCT03454620
A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy
Phase 1b/2a Study of GC1118 in Combination With Irinotecan or FOLFIRI in Patients With Recurrent/Metastatic Solid Tumor
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Green Cross Corporation · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | irinotecan | GC1118 combination with irinotecan |
| DRUG | FOLFIRI | GC1118 combination with FOLFIRI |
Timeline
- Start date
- 2018-04-02
- Primary completion
- 2021-09-17
- Completion
- 2022-01-10
- First posted
- 2018-03-06
- Last updated
- 2022-03-03
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03454620. Inclusion in this directory is not an endorsement.