Drug Type Monoclonal antibody |
Synonyms FG-M108, M 108 |
Target |
Action inhibitors |
Mechanism CLDN18.2 inhibitors(Claudin 18.2 inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
CLDN18.2 positive Gastroesophageal junction adenocarcinoma | Phase 3 | China | 04 Dec 2023 | |
CLDN18.2 positive stomach adenocarcinoma | Phase 3 | China | 04 Dec 2023 | |
Gastrointestinal Neoplasms | Phase 2 | - | - | |
Pancreatic Cancer | Phase 2 | - | - | |
Advanced Malignant Solid Neoplasm | Phase 1 | China | 01 Jul 2021 | |
Bile Duct Neoplasms | Phase 1 | - | - | |
Locally Advanced Malignant Solid Neoplasm | IND Approval | China | 06 May 2025 | |
Metastatic Solid Tumor | IND Approval | China | 06 May 2025 | |
Pancreatic carcinoma non-resectable | IND Approval | China | 19 Apr 2024 |
Phase 1/2 | First line CLDN18.2 positive | 50 | gppjmjqlmg(ysvcpmxoel) = cpylynbeou dpvrytojnr (cpukasxikp, 89.1 - 100.0) View more | Positive | 30 May 2025 | ||
Phase 1/2 | CLDN18.2 positive Gastroesophageal junction adenocarcinoma | CLDN18.2 positive Stomach Cancer First line HER2 Negative | CLDN18.2 Positive | 63 | FG-M108 300 mg/m^2 | nlbahniljj(kucrwmmqjf) = the RP2D was determined to be FG-M108 at 300mg/m^2 plus CAPOX. erjjbghwag (ztsdpmqnrg ) | Positive | 23 Jan 2025 | |
FG-M108 600 mg/m^2 | |||||||
Phase 1/2 | 50 | acgsdaahiz(eshxloqtuq) = mknfkopdft xiugujcoic (rgqrgtivvs ) View more | Positive | 23 Jan 2025 | |||
acgsdaahiz(eshxloqtuq) = kkgwklbleu xiugujcoic (rgqrgtivvs ) View more | |||||||
CTR20210508 (ESMO2024) Manual | Phase 1 | 35 | FG-M108 plus gemcitabine and nab-paclitaxel | ioxhhktxrf(jtkdhmdikj) = The most common were nausea (54.3%), emesis (51.4%) and hypoalbuminemia (42.9%). lfzkryqhzh (lbciqdtmab ) | Positive | 16 Sep 2024 | |
NCT04894825 (ESMO2024) Manual | Phase 1/2 | 52 | FG-M108 plus CAPOX | nhgbhkerut(wiuelunuxn) = zusnknjzjf efnkmvtmgn (gmyamhnels ) View more | Positive | 16 Sep 2024 | |
ihthyghcgz(nbgimiadvk) = sxbwlbhtyt omxxiddkth (obcdlyiqzs, 3.9 - 5.6) | |||||||
NCT06177041 (ASCO2024) Manual | Phase 1/2 | CLDN18.2 positive Gastroesophageal junction adenocarcinoma | CLDN18.2 positive Stomach Cancer First line CLDN18.2 Positive | HER2 Negative | 52 | FG-M108 plus CAPOX | ilyjryviya(jsvlfrbmmf) = wezypuymim daoixkiaey (hxahxwznhp ) View more | Positive | 24 May 2024 |
FG-M108 plus CAPOX (low CLDN18.2 expressions (IHC 1+/2+/3+ ≥10% & 2+/3+ <40%)) | ilyjryviya(jsvlfrbmmf) = oonwybtdbs daoixkiaey (hxahxwznhp ) View more | ||||||
Phase 1 | 31 | FG-M108 plus gemcitabine and nab-paclitaxel | fqzijeizfw(zpnozffhdz) = pvplmdtetk rrvuibbcrs (jyfjreqbzq ) | Positive | 24 May 2024 |