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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4798 - A first-in-human phase 1 study of GC1118, a novel monoclonal antibody inhibiting epidermal growth factor receptor (EGFR), in patients with colorectal cancer and gastric/GEJ cancer

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Clinical Research

Tumour Site

Colon and Rectal Cancer

Presenters

Do-Youn Oh

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

D. Oh1, K. Lee2, S. Han3, J.W. Kim4, J. Shin5, S. Jo6, N.H. Kim7, A. Woo8, J. Won9, S. Hahn10, H. Lee11, W.H. Kim12, Y. Bang13

Author affiliations

  • 1 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 2 Department Of Internal Medicine, Seoul National University Bundang Hospital, 463-707 - Seongnam/KR
  • 3 Internal Medicine, Seoul National University Hospital, 101 - Seoul/KR
  • 4 Oncology, Seoul National University Bundang Hospital, Seongnam/KR
  • 5 Department Of Dermatology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam/KR
  • 6 Dermatology, Seoul National University Hospital, 101 - Seoul/KR
  • 7 -, Green Cross Corp., Yongin/KR
  • 8 Clinical Development, Green Cross Corporation, 93 - Yongin/KR
  • 9 Oncology Team, MOGAM Institude for Biomedical Research, 446-799 - Gyeonggi-do/KR
  • 10 Division Of Medical Statistics, Seoul National University Hospital, 110-744 - Seoul/KR
  • 11 Clinical Pharmacology, Seoul National University Hospital, 101 - Seoul/KR
  • 12 Pathology, Seoul National University Hospital, 101 - Seoul/KR
  • 13 Internal Medicine (medical Oncology), Seoul National University Hospital, 110-744 - Seoul/KR
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Resources

Abstract 4798

Background

GC1118 is a novel anti-EGFR monoclonal antibody and has unique binding epitopes and different ligand binding inhibitory activity compared to cetuximab and panitumumab. In dose escalation part of a first-in-human phase 1 study, RP2D were determined as 4 mg/kg, in weekly dosing schedule (NCT02352571). DLT was skin toxicity. Here we report efficacy and safety data of GC1118 in patients (pts) with colorectal cancer (CRC) and gastric cancer (GC) tested in dose expansion part.

Methods

Cohort 1 (C1) recruited pts with metastatic CRC with no prior EGFR antibody treatment who have failed to 5-FU, oxaliplatin and irinotecan. Cohort 2 (C2) enrolled pts with metastatic CRC with resistance to prior EGFR antibody. Cohort 3 (C3) enrolled pts with EGFR over-expressing (2+,3+) metastatic GC cancer who have failed to standard treatment. GC1118 was administrated on days 1, 8, 15 and 22 every 4 weeks.

Results

A total of 39 pts were enrolled (C1: 14, C2:12, C3:13). Evaluable pts were 12 in each cohort. In C1, SD was observed in 58.33% (7/12) and there was no CR/PR case. In C2, 2 patients (16.67%) obtained PR, 1 SD (8.33%), and 9 PD (75.0%). In C3, PR was 8.33% (1/12), SD 16.67% (2/12), and PD 75.0%. The progression-free survival (PFS) were 14 weeks (95% CI: 7.1-30.1), 6.93 weeks (95% CI: 4.2-14.8), and 6.7 weeks (95% CI: 5.0-11.0), respectively Adverse event (AE) was observed in 97.4% of patients and treatment-related AE (TRAE) occurred in 92.3% of patients. Skin toxicity (all grade) was observed in 89.7% of patients (35/39), stomatitis 20.51%( all grade 1/2), and diarrhea 17.95% (all grade 1/2). Dose reduction due to AE was required in 23.08% of patients (9/39), and dose interruption due to AE was needed in 58.9% of patients (23/39). TRAE higher than grade 3 was observed in 20.5% of patients (8/39). Among them, skin toxicity was most common (12.8%, 5/39 patients) There was no treatment-related death.

Conclusions

GC1118 showed promising anti-tumor activity, especially in CRC with resistance to prior EGFR antibody with 16.7% PR, even in heavily treated population. GC1118 was generally well tolerated, and skin toxicities were by far the most common AEs.

Clinical trial identification

Legal entity responsible for the study

Green Cross Corp., Seoul National University Hospital.

Funding

Green Cross Corp.

Editorial Acknowledgement

Disclosure

N.H. Kim, A. Woo, J. Won: Employee: Pharmaceutical company. All other authors have declared no conflicts of interest.

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