 |
0 Diseases |  |
4 Trials |
|
4 Trials |  |
19 News |  |
- paclitaxel / Generic mfg.
Anti-EGFR in combination with paclitaxel as second-line therapy for gastric cancer with EGFR overexpression (Section 49) - Mar 5, 2024 - Abstract #AACR2024AACR_6661;
Abstract is embargoed at this time.
- || GC-1118A / GC Biopharma
P2 data, Journal: A multicenter, phase II trial of GC1118, a novel anti-EGFR antibody, for recurrent glioblastoma patients with EGFR amplification. (Pubmed Central) - Aug 4, 2023
Abstract is embargoed at this time. This study did not meet the primary endpoint (PFS6); however, we found that immune signatures were significantly upregulated in the tumors with regression upon GC1118 therapy, which signifies the potential of immune-mediated antitumor efficacy of GC1118.
- | GC-1118A / GC Biopharma
Trial completion, Enrollment change: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification (clinicaltrials.gov) - May 12, 2023
P2, N=13, Completed, Sponsor: Samsung Medical Center
This study did not meet the primary endpoint (PFS6); however, we found that immune signatures were significantly upregulated in the tumors with regression upon GC1118 therapy, which signifies the potential of immune-mediated antitumor efficacy of GC1118. Unknown status --> Completed | N=23 --> 13
- | GC-1118A / GC Biopharma
Enrollment change, Trial primary completion date, Combination therapy: EGFR-targeted Therapy for Gastric Cancer (clinicaltrials.gov) - Nov 30, 2022
P2, N=19, Recruiting, Sponsor: National Cancer Center, Korea
Unknown status --> Completed | N=23 --> 13 N=38 --> 19 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||| GC-1118A / GC Biopharma
Trial completion, Trial completion date, Combination therapy, Metastases: A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy (clinicaltrials.gov) - Mar 3, 2022
P1b/2a, N=53, Completed, Sponsor: Green Cross Corporation
N=38 --> 19 | Trial primary completion date: Dec 2022 --> Dec 2023 Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jan 2022
- || GC-1118A / GC Pharma
Clinical, PK/PD data, Journal: A Target-Mediated Drug Disposition Population Pharmacokinetic Model of GC1118, a Novel Anti-EGFR Antibody, in Patients with Solid Tumors. (Pubmed Central) - Jan 4, 2022
Monte-Carlo simulation experiments of the PK profiles and EGFR receptor occupancies (RO) by GC1118 based on the final model showed that Q1W at 4 or 5 mg/kg will produce a better anti-tumor effect than Q2W at 8 mg/kg. Because GC1118 was safer at 4 mg/kg than 5 mg/kg in the phase I study, we suggest to test the 4 mg/kg Q1W regimen in further clinical trials with GC1118.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono, GC-1118A / GC Pharma
Therapeutic efficacy of GC1118, a novel anti-EGFR antibody, against glioblastoma with high EGFR amplification in patient-derived xenografts (Exhibit Hall D) - Nov 16, 2021 - Abstract #SNO2021SNO_530;
Our study supports the importance of patient stratification based on EGFR copy number variation in clinical trials for GBM. The superiority of GC1118 over other EGFR mAbs in GBM tumors should be assessed in future studies.
- | GC-1118A / GC Biopharma
Enrollment open, Enrollment change, Combination therapy: EGFR-targeted Therapy for Gastric Cancer (clinicaltrials.gov) - May 12, 2021
P2, N=38, Recruiting, Sponsor: National Cancer Center, Korea
The superiority of GC1118 over other EGFR mAbs in GBM tumors should be assessed in future studies. Not yet recruiting --> Recruiting | N=85 --> 38
- || GC-1118A / GC Biopharma
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy (clinicaltrials.gov) - Jan 19, 2021
P1b/2a, N=53, Active, not recruiting, Sponsor: Green Cross Corporation
Not yet recruiting --> Recruiting | N=85 --> 38 Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Jun 2021 | Trial primary completion date: Mar 2020 --> Jun 2021
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, GC-1118A / GC Pharma
Clinical, Journal: Therapeutic Efficacy of GC1118, a Novel Anti-EGFR Antibody, against Glioblastoma with High EGFR Amplification in Patient-Derived Xenografts. (Pubmed Central) - Nov 5, 2020
Our study supports the importance of patient stratification based on EGFR copy number variation in clinical trials for GBM. The superiority of GC1118 over other EGFR mAbs in GBM tumors should be assessed in future studies.
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, GC-1118A / Green Cross
Clinical, P1 data, Journal: A First-in-Human Phase I Study of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Advanced Solid Tumors. (Pubmed Central) - Jul 29, 2020
GC1118 showed promising antitumor activity and was well tolerated. Infrequent diarrhea compared with other anti-EGFR antibodies might be advantageous for further development.
- | GC-1118A / GC Biopharma
Trial completion date, Trial primary completion date: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification (clinicaltrials.gov) - Jul 15, 2020
P2, N=23, Recruiting, Sponsor: Samsung Medical Center
Infrequent diarrhea compared with other anti-EGFR antibodies might be advantageous for further development. Trial completion date: Jul 2020 --> Jul 2021 | Trial primary completion date: Jan 2020 --> Dec 2020
- fluorouracil / Generic mfg., irinotecan / Generic mfg., GC-1118A / Green Cross
[VIRTUAL] Phase Ib/IIa study of GC1118 in combination with irinotecan or FOLFIRI in patients with metastatic solid tumors. (Poster Board 322) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1542;
P1b/2a
Preliminary results of GC1118 and FOLFIRI as a 2nd line treatment in mCRC suggests promising antitumor activity and acceptable safety profile. Research Funding: Green Cross Corporation
- || Erbitux (cetuximab) / Eli Lilly, EMD Serono, GC-1118A / Green Cross
Clinical, Journal: Promising Therapeutic Efficacy of GC1118, an Anti-EGFR Antibody, against KRAS Mutation-Driven Colorectal Cancer Patient-Derived Xenografts. (Pubmed Central) - Apr 14, 2020
Epidermal growth factor receptor (EGFR)-targeted monoclonal antibodies, including cetuximab and panitumumab, are used to treat metastatic colorectal cancer (mCRC)...In support of these findings, a preliminary improved anti-cancer response was observed in a CRC PDX harboring mutated KRAS with intrinsically high AKT activity using GC1118 combined with the dual PI3K/mammalian target of rapamycin (mTOR)/AKT inhibitor BEZ-235, without observed toxicity. Taken together, the superior antitumor efficacy of GC1118 alone or in combination with PI3K/mTOR/AKT inhibitors shows great therapeutic potential for the treatment of KRAS-mutant mCRC with elevated ratios of high- to low-affinity EGFR ligands and PI3K-AKT pathway activation.
- | fluorouracil / Generic mfg., Erbitux (cetuximab) / Eli Lilly, EMD Serono, GC-1118A / Green Cross
Journal: GC1118, a novel anti-EGFR antibody, has potent KRAS mutation-independent antitumor activity compared with cetuximab in gastric cancer. (Pubmed Central) - Feb 14, 2020
Taken together, GC1118 alone or in combination with cytotoxic chemotherapeutic agents exerted more potent anti-tumor effects than cetuximab in GC cells, regardless of KRAS status. These findings support the further clinical development of GC1118 for the treatment of GC.
- GC-1118A / Green Cross
Preclinical in vivo screening to predict responder patients depend on EGFR status (Poster Area (Hall 4)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_2647;
Legal entity responsible for the study: The authors. Funding: The Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea.
- | GC-1118A / GC Biopharma
New P2 trial, Combination therapy: EGFR-targeted Therapy for Gastric Cancer (clinicaltrials.gov) - Sep 4, 2019
P2, N=85, Not yet recruiting, Sponsor: National Cancer Center, Korea
- | GC-1118A / GC Biopharma
New P2 trial: GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification (clinicaltrials.gov) - Aug 7, 2018
P2, N=23, Recruiting, Sponsor: Samsung Medical Center
- |||| GC-1118A / GC Biopharma
Enrollment open, Combination therapy, Metastases: A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy (clinicaltrials.gov) - Apr 4, 2018
P1b/2a, N=53, Recruiting, Sponsor: Green Cross Corporation
Funding: The Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea. Not yet recruiting --> Recruiting
- ||| GC-1118A / GC Biopharma
New P1 trial, Metastases: Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer (clinicaltrials.gov) - Feb 2, 2015
P1, N=66, Recruiting, Sponsor: Green Cross Corporation