On December 20, RemeGen announced that Phase I clinical trials of RC118 in Australia and China progressed well, showing favorable safety and tolerability.
RC118 for injection is an innovative antibody drug conjugate(ADC) independently developed by RemeGen for the treatment of patients with locally advanced unresectable or metastatic malignant solid tumors with positive expression of Claudin 18.2.
In July 2021, RC118 received the ethical approval for Phase I clinical trial issued by the Australian Human Research Ethics Committee, and further received the approval for Phase I clinical trial from the Center for Drug Evaluation (CDE) of the NMPA in September and started clinical studies in China and Australia at the end of the same year, mainly to explore its tolerability, safety and recommended phase II dose (RP2D) in human.
Preliminary clinical studies have shown that no dose limiting toxicity (DLT) events have been observed in clinical trials conducted in China and Australia, indicating that RC118 is safe and well tolerated in both Chinese and Australians.
Before then, RemeGen announced that RC118 has been granted two orphan drug designations by the US Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer.
