Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 18

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

Date

14 Sep 2024

Session

Poster session 18

Topics

Targeted Therapy

Tumour Site

Pancreatic Adenocarcinoma

Presenters

Funan Liu

Citation

Annals of Oncology (2024) 35 (suppl_2): S923-S936. 10.1016/annonc/annonc1605

Authors

F. Liu1, Y. Zhang2, S. Zhang3, J. Gong4, M. Zhang4, X. Liang5, J. Wang6, Y. LI7, Z. Jin8, Y. Yang7, L. Shen9

Author affiliations

  • 1 Phase I Clinical Trials Center, The First Affiliated Hospital of China Medical University, 110001 - Shenyang/CN
  • 2 Gi Oncology, Cancer Hospital Affiliated to Harbin Medical University, 150084 - Harbin/CN
  • 3 Gastrointestinal Oncology, Shandong Cancer Hospital, 250117 - Jinan/CN
  • 4 Gastrointestinal Oncology, Peking University Cancer Hospital, 100142 - Beijing/CN
  • 5 Medicine Department, HuBei Cancer Hospital, 430072 - Wuhan/CN
  • 6 Gastrointestinal Oncology, Affiliated Hospital of Jining Medical College, 272129 - Jining/CN
  • 7 Clinical Research, FutureGen Biopharm, Beijing/CN
  • 8 Clinical Research, FutureGen Biopharm, 102629 - Beijing/CN
  • 9 Department Of Gastrointestinal Oncology, Key Laboratory Of Carcinogenesis And Translational Research (ministry Of Education/beijing), Peking University Cancer Hospital & Institute, 100142 - Beijing/CN

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 1530P

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.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.