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FG-M108 in Claudin18.2-positive advanced pancreatic cancer
NCT07383922Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2026
- Primary completion
- Jun 2030
- Countries
- 1
- Modality
- Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- M108
- Conditions
- pancreatic ductal adenocarcinoma (PDAC)
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Overview
Phase 3, randomised, double-blind trial in pancreatic ductal adenocarcinoma (PDAC) comparing FG-M108 + Chemotherapy with Placebo + Chemotherapy (2 arms). Primary endpoint: Overall Survival at 24 months. Planned start Feb 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
FG-M108 + Chemotherapy
FG-M108 combined with nab-paclitaxel and gemcitabine
Placebo + Chemotherapy
Placebo combined with nab-paclitaxel and gemcitabine
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Who it enrols
Patients aged 18-80 with histologically confirmed unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma, CLDN18.2-positive (≥40% tumor cells with ≥2+ membrane staining), ECOG 0-1, no prior systemic therapy (or >6 months since neoadjuvant/adjuvant therapy), with adequate organ function and life expectancy ≥3 months
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Objective Response Rate
Disease Control Rate
Duration of Response
Adverse Events
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