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.
Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
Age 18-80 years (inclusive), any gender;
Histologically or cytologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, without prior systemic therapy; or for subjects who have received prior neoadjuvant/adjuvant chemotherapy, the time from the last treatment to disease recurrence is >6 months;
Able to provide archived or fresh pathological tissue for CLDN18.2 testing, with central laboratory testing confirming tumor tissue CLDN18.2 positive (defined as ≥40% of tumor cells with CLDN18.2 membrane staining ≥2+ by central laboratory IHC);
Have received a live vaccine within 4 weeks prior to randomization;
Have received radiotherapy within 2 weeks prior to randomization;
Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;
Have undergone major surgery within 4 weeks prior to randomization;
Parallel
FG-M108
DrugFG-M108 monoclonal antibody will be administered as a minimum 2-hour Intravenous drip.
nab paclitaxel
DrugNab-paclitaxel will be administered as an Intravenous drip.
Gemcitabine (GEM)
DrugGemcitabine will be administered as an Intravenous drip.
Placebo for FG-M108
DrugPlacebo will be administered as an Intravenous drip.
Overall Survival (OS)
OS is defined as the time from randomization to deathdue to any cause.
Progression Free Survival (PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Disease control rate (DCR)
DCR is defined as the proportion of participants who have a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by investigator evaluation per RECIST 1.1.
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
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