1530P - Preliminary result of a phase Ib study: Efficacy and safety of FG-M108 plus gemcitabine and nab-paclitaxel in patients with Claudin18.2 positive locally advanced unresectable or metastaticpancreatic cancer

Background

Pancreatic cancer (PC) is an aggressive malignancy with limited treatments and poor outcomes. Claudin 18.2 (CLDN18.2) antigen, a gastric-specific tightjunciton protein has been described frequently expressed in malignant gastrointestinal cancers including pancreatic cancer. FG-M108 is a human monoclonal antibody specifically targeting CLDN18.2 with optimal affinity and enhanced antibody-dependent cellularcytotoxicity (ADCC) activity.

Methods

with one cohort of an ongoing phase 1 study of FG-M108, eligible PC patients with positive CLDN18.2 expression (IHC 1+/2+/3+≥10%) were enrolled. The patients received FG-M108 (intravenous, 300 mg/m², day1) plus gemcitabine (intravenous, 1000 mg/m², day1,8) and nab-paclitaxel (intravenous, 125 mg/m², day1,8) of each 3-week cycle. Primary endpoints included the incidence of adverse events (AEs) and preliminary clinical efficacy (ORR, DCR, DOR, PFS, OS, et al.).

Results

As of April 19, 2024, 35 patients received FG-M108 plus chemotherapy. Of 30 patients who received at least once tumor evaluation, ORR was 30.0% (9/30) and DCR was 100% (30/30), with one patient is still on treatment for 13.5 months. The most common M108-related AEs were nausea (54.3%), emesis (51.4%) and hypoalbuminemia (42.9%). Serious M108-related AEs occurred in 5 (5/35) participants. No M108-related grade 4 or 5 AEs and no treatment-related deaths were reported.

Conclusions

FG-M108 plus gemcitabine and nab-paclitaxel as first-line treatment in patients with Claudin-18.2+ advanced PC showed promising clinical efficacy with manageable safety. the safety and efficacy, especially PFS and OS will be further evaluated.

Clinical trial identification

CTR20210508.

Editorial acknowledgement

Legal entity responsible for the study

FutureGen Biopharm.

Funding

FutureGen BioPharm.

Disclosure

F. Liu, J. Gong, M. Zhang, X. Liang, J. Wang: Non-Financial Interests, Institutional, Local PI: FutureGen Biopharm. Y. Zhang, S. Zhang: Financial Interests, Institutional, Local PI: FutureGen Biopharm. Y. LI, Z. Jin, Y. Yang: Financial Interests, Institutional, Full or part-time Employment: FutureGen Biopharm. L. Shen: Non-Financial Interests, Institutional, Coordinating PI: FutureGen Biopharm.