GC Pharma said Thursday that it has launched phase 1b/2a clinical trials for GC1118, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody that treats colorectal cancer, in patients with solid cancer.
Abnormal overexpression and activity of EGFR lead to proliferation and metastasis of cancer cells. GC1118 binds to the EGFR to prevent such growth signal and inhibit the spread of cancer. The candidate also boosts immune cells to induce cancer cell death through cytotoxicity.
The drug is a new biopharmaceutical candidate with a unique binding mechanism and action mechanism compared to conventional EGFR target therapeutic drugs of the multinational pharmaceutical companies. It also has a broad and excellent inhibitory effect on various kinds of EGFR growth factors.
The announcement comes after the company injected the drug to its first patient in the optimal study trial. This clinical trial in patients with relapsed and metastatic solid tumors will administer GC1118 in combination with irinotecan or the Folinic acid, fluorouracil and irinotecan (FOLFIRI) method. Seoul National University Hospital and Seoul National University Bundang Hospital (SNUBH) will be carrying out the trials.
The combined treatment is designed to maximize the therapeutic effect of GC1118 as various global studies showed that the combination of conventional chemotherapy with a targeted chemotherapeutic agent showed a higher therapeutic effect compared to a single administration.
During the trial, the company plans to investigate the appropriate dosage of GC1118 and irinotecan or FOLFIRI method in phase 1b clinical trials, while evaluating the safety and efficacy of the drug in a more substantial patient pool in phase 2b clinical trials.
“After seeing the result of the trials, we plan to expand indications of GC1118 to gastric cancer, along with colorectal cancer,” an official at GC Pharma said. “The company expects that if the drug development is successful, it will greatly expand treatment options for patients.”
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