A Study of FG-M108+Chemotherapy vs Placebo+Chemotherapy in Claudin18.2-positive Pancreatic Cancer

Pancreatic cancer, which stands as one of the most lethal malignancies and a leading cause of cancer-related deaths globally, poses a significant challenge to human health worldwide. However, standard chemotherapeutic regimens show limited effectiveness in advanced pancreatic cancer, creating an urgent demand to investigate and develop novel therapeutic targets and combination treatment strategies. The primary objective of this study is to evaluate the efficacy of FG-M108 combined with gemcitabine and nab-paclitaxel (Nab-P+GEM) versus placebo combined with Nab-P+GEM as first-line treatment, as measured by overall survival (OS). This study will also assess safety, tolerability, pharmacokinetics, and the immunogenicity profile of FG-M108 monoclonal antibody, along with its impact on quality of life.

NCT Number	NCT07383922
Lead Sponsor	FutureGen Biopharmaceutical (Beijing) Co., Ltd
Conditions	Pancreatic Cancer
Enrollment	524 participants
Start Date	2026-02-28
Primary Completion	2030-06-30 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-04