GC has come up with optimal interim results for its phase 1b/2a clinical trials for GC1118, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody for treating colorectal cancer.
|GC headquarters in Yongin, Gyeonggi Province.|
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 EGFR growth factors and boosts immune cells to induce cancer cell death through cytotoxicity.
GC is conducting the trial in patients with relapsed and metastatic solid tumors by administering GC1118 in combination with irinotecan or the folinic acid, fluorouracil, and irinotecan (FOLFIRI) method at various local medical institutions, including Seoul National University Hospital and Seoul National University Bundang Hospital.
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 had a higher therapeutic effect compared to a single administration.
The company aims 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.
In the phase 1b clinical trial, the company enrolled 13 patients and administered either 3mg/kg of GC1118 with irinotecan or FOLFIRI.
“Dose-limiting toxicity occurred in two patients in the irinotecan group and one patient in the FOLFIRI group,” the company said. “In turn, the company determined that 3mg/kg of GC1118 was the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D).
Adverse events of grade 3 or higher included neutropenia (61.5 percent), skin rash (15.4 percent), and diarrhea (15.4 percent), while dose reductions due to GC1118-related adverse events were required in six patients, the company added.
Among 10 response-evaluable patients in the Phase 1b clinical trial, there were three partial response (PR) and six stable-disease (SD) patients, while the median progression-free survival was 12 months.
Based on the results, the company is conducting phase 2a clinical trials in 29 patients.
“In stage 1 of phase 2a, the company observed four PR patients and five SD patients,” the company said. “The company has since moved to stage 2 of the clinical trial and is enrolling 20 additional patients.”
GC medical director Kim Jin also said, “Although the company is at the early stages of the clinical trials, it has managed to confirm the drug’s anticancer effect.”
GC will follow up with clinical trials to develop the medicine as a second-line treatment for patients who have failed in first-line treatment, Kim added.
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