China-based Jacobio Pharma (HKG: 1167) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a pivotal clinical study for its novel KRAS G12C inhibitor, glecirasib, in pancreatic cancer. This development marks glecirasib as the world’s first KRAS inhibitor to reach the pivotal trial stage for this specific indication.
Design of the Pivotal Clinical Study
The upcoming multi-center, single-arm, open-label study will evaluate the efficacy and safety of glecirasib as a monotherapy for the second line treatment or above of pancreatic cancer patients with a KRAS G12C mutation. The data generated from this study will be instrumental in supporting a future New Drug Application (NDA) filing for pancreatic cancer.
Glecirasib’s Development and Ongoing Trials
Glecirasib, developed in-house by Jacobio, is currently the subject of several Phase I/II clinical trials in China, the US, and Europe. These trials are focused on patients with advanced solid tumors that harbor a KRAS G12C mutation. Among these trials is a pivotal clinical trial in non-small cell lung cancer (NSCLC) in China, a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 antibody, and cetuximab.-Fineline Info & Tech
