Jacobio Pharma has received approval from the Center for Drug Evaluation (CDE) to initiate a pivotal study of glecirasib for the treatment of pancreatic cancer in China.
The open-label, multi-centre, single-arm study will assess the safety and efficacy of the KRAS G12C inhibitor glecirasib as a single agent for second line treatment in patients with pancreatic cancer harbouring the KRAS G12C mutation.
Jacobio chief medical officer Dr Andrea Wang-Gillam said: “The pivotal study of pancreatic cancer is the second approved registrational study after non-small cell lung cancer.
“We hope to work with clinical study investigators to jointly advance the clinical trials and strive to bring more treatment options to cancer patients with KRAS G12C-mutated as soon as possible.”
The company will use the results from this trial to submit a new drug application (NDA) for pancreatic cancer.
The overall survival rate in pancreatic cancer patients as assessed over five years is only 5% and approximately 90% of them have different types of KRAS mutations.
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Along with glecirasib, Jacobio is developing KRASmulti, KRAS G12D, and other projects for pancreatic cancer patients.
Jacobio has also commenced various Phase I/II trials of glecirasib in Europe and the US to treat patients with advanced solid tumours harbouring the KRAS G12C mutation.
A pivotal clinical trial in China has been initiated for treating patients with non-small cell lung cancer.