drugset / Trial / NCT06341335

A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06341335

Phase 3 Recruiting 506 enrolled Akeso
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.

Timeline

Start
2024-06-19
Primary completion
2026-11
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody Intravenous
Subject pulocimab Monoclonal antibody Intravenous
Background Paclitaxel Small molecule Intravenous

Indications