NCT06341335

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

A Randomized, Double-blind, Phase 3 Study Of Cadonilimab (AK104) Plus Pulocimab (AK109) And Paclitaxel Versus Paclitaxel In Patients With Advanced Gastric Or Gastroesophageal Junction Adenocarcinoma Who Failed First-line Immunochemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric and Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	cadonilimab	iv, q3w
DRUG	pulocimab	iv, q3w
DRUG	paclitaxel	iv, q3w
DRUG	placebo	iv, q3w

Timeline

• Start date: 2024-06-19
• Primary completion: 2026-11-01
• Completion: 2027-07-01
• First posted: 2024-04-02
• Last updated: 2024-06-24

Locations

1 site across 1 country: China