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Clinical trial

A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.

NCT06177041 is registered in ClinicalTrials.gov with FutureGen Biopharmaceutical (Beijing) Co., Ltd as lead sponsor.

NCT NCT06177041
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Multi-Center, Double-Blind, Randomized, Efficacy and Safety Study of M108 Monoclonal Antibody Plus CAPOX Versus Placebo Plus CAPOX as First-line Treatment for Claudin (CLDN) 18.2-Positive, HER2-Negative, PD-L1 CPS<5, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma.
Lead sponsor
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Phase
Phase 3
Overall status
Recruiting
Start date
December 25, 2023
Completion date
April 11, 2027
Enrollment
486 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

locally advanced unresectable or metastatic gastric cancer, locally advanced unresectable or metastatic gastroesophageal junction (gej) adenocarcinoma