Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer
|ClinicalTrials.gov Identifier: NCT02352571|
Recruitment Status : Unknown
Verified February 2016 by Green Cross Corporation.
Recruitment status was: Recruiting
First Posted : February 2, 2015
Last Update Posted : July 6, 2016
The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV solid tumors.
The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis Gastric Cancer Colorectal Cancer||Biological: GC1118||Phase 1|
An open-label, single-arm, multi-center, phase 1, dose-escalation study will be conducted to define the MTD/RP2D, safety, PK, immunogenicity and antitumor activity of GC1118 in patients with refractory disease for whom no standard therapy is available.
This study is in three parts: a dose escalation segment (Part A), a cohort expansion (Part B) and biweekly administration(Part C). In part A, a dose escalation schema will be applied in dose level cohorts. GC1118 will be administered weekly on Study Day 1, 8, 15, and 22 of each 28-day cycle by IV infusion. Dose escalation may occur as described in the study protocol. Once the MTD has been established during Part A, the MTD cohort will be expanded in part B. And GC1118 will be administered biweekly on Study Day 1, 15 each 28-day cycle by IV infusion in part C.
Study assessments will include AE monitoring including physical examination, vital signs and clinical laboratory tests, ECG monitoring, PK analysis of serum GC1118, an assessment of potential anti-GC1118 antibody response and an exploration of potential prognostic and pharmacodynamic biomarkers.
Tumor response assessments using Study Day 36 CT/MRI scans will be performed approximately five weeks after the first GC1118 dose for each patient (Part A only). Patients with evidence of disease regression (partial or complete response or stable disease by RECIST criteria) will be allowed to continue therapy at the same dose. Subsequent cycles will consist of administration of GC1118 on Day 1, 8, 15, and 22 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part A,B and Day 1, 15 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part C.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-label, Dose Escalation (Part A) and Cohort Expansion (Part B) Phase 1 Study to Investigate the Safety, Tolerability, and Immunogenicity and to Determine Maximum Tolerated Dose and Recommended Phase 2 Dose of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancers|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Single group assignment
GC1118 recombinant human anti-EGFR antibody
For Part A, GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in the dose escalation cohorts, starting 0.3mg/kg until Maximum Tolerated Dose is defined.
For Part B, the defined MTD/RP2D of GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in patients with stage IV of gastric cancer, colorectal cancer or other cancers.
For Part C, GC1118 will be administered by IV infusion once every 2 weeks for 4 weeks (28-day cycles) in patients with all stage IV advanced solid cancers.
Part A, Part B and Part C participants who qualify for subsequent cycles will receive continued GC1118 until evidence of progression of disease.
- Occurrence of Dose Limiting Toxicity (DLT) [ Time Frame: Approx. 6 months ]
- Frequency of Adverse Events [ Time Frame: Approx. 6 months ]
- Changes in safety parameters, laboratory values, vital signs and physical examinations [ Time Frame: Approx. 6 months ]Vital sign assessment will include systolic and diastolic blood pressure, heart rate, respiration rate and temperature. Laboratory values will include hematology and clinical chemistry.
- Overall Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 [ Time Frame: Approx. 6 months ]
- Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 [ Time Frame: Approx. 6 months ]
- Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 (Part B) [ Time Frame: Approx. 6 months ]
- Time versus plasma concentration profiles and basic PK parameters of GC1118 [ Time Frame: Approx. 6 months ]
- Presence of Human Anti Drug Antibody [ Time Frame: Approx. 6 months ]Assess whether participants develop an immune response to GC1118
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352571
|Contact: Ahmi Woo||+ 82 31 260 email@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Yung Jue Bang, M.D., Ph.D. firstname.lastname@example.org|
|Principal Investigator: Yung Jue Bang, Ph.D.|