Phase Ib trial will be conducted at approximately 15 investigational sites including Beijing Cancer Hospital. The primary objectives of the overall study are to evaluate the safety/tolerability, efficacy and pharmacokinetic profile of GFH375 in combination with cetuximab or chemotherapy. In the phase II trial, the combination of GFH375 with chemotherapy (albumin-bound paclitaxel and gemcitabine, AG) will be administered to untreated patients with advanced PDAC, while the combination of GFH375 wi
Among 59 heavily pretreated patients with advanced disease (nearly 70% in the third- or later-line setting) who had their first dose at least 4 months prior to data cut-off date and finished at least one post-treatment tumor assessment: the objective response rate was 40.7%; the disease control rate was 96.7%; the median progression-free survival (PFS) was 5.52 months and the 4-month OS rate was 92.2%.
GFH276 is the third candidate in GenFleet’s RAS-targeted matrix to enter clinical research, following successful development of a marketed KRAS G12C inhibitor (fulzerasib) and a phase-II KRAS G12D inhibitor (GFH375).
"Over the past eight years, we've built a powerful pipeline that includes the first China-developed KRAS inhibitor. Anchored by a leading-edge RAS-targeted matrix, the pipeline tackles critical unmet needs globally in cancers such as pancreatic, lung, and colorectal cancer. Riding the waves of innovation, we've kept moving forward and delivered novel therapeutics and solid out-licensing milestones, for the benefit of patients and the value creation of shareholders."
The conference will take place in Barcelona, Spain from Sept. 6-9, with a mini oral presentation scheduled for Sept. 7 to highlight the efficacy and safety data of GFH375 in patients with advanced non-small cell lung cancer (NSCLC).
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Programs with FTD are eligible for more frequent interactions with FDA to discuss the candidate’s development plan, as well as a rolling review of NDA or BLA to facilitate Accelerated Approval and Priority Review if relevant criteria are met.
Fulzerasib was the first China-developed KRAS G12C inhibitor that had its NDA approved with Priority Review Designation in Aug 2024 by NMPA. Fulzerasib has also earned Class 1 recommendation in treatment for KRAS G12C-mutant NSCLC in the 2025 CSCO guidelines, offering patients a new option of targeted therapy with durable efficacy and good tolerability.
Among 49 patients orally administered at daily dosages of 400 or 600 mg: 43 patients who received at least one post-treatment tumor assessment achieved an objective response rate (ORR) of 42% and a disease control rate (DCR) of 91%; the ORR was 52% and DCR was 100% among 23 efficacy-evaluable PDAC patients, and the ORR was 42% and DCR was 83% among 12 efficacy-evaluable NSCLC patients.
