drugset / Trial / NCT06196697

AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

NCT06196697

Phase 2 Recruiting 50 enrolled Harbin Medical University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

Timeline

Start
2024-04-10
Primary completion
2027-01
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 6 mg/kg Intravenous
Subject Cadonilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Cadonilimab Monoclonal antibody 15 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Ivonescimab Monoclonal antibody 20 mg/kg Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background S-1 Small molecule 40 mg/m2 Oral