NCT06196697

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

A Phase II, Single Arm, Single Center Study of Cadonilimab(AK104) in Combination With Ivonescimab(AK112) Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for AK104 in combination with AK112 and SOX/XELOX, and a dose confirmation phase which will further characterize the treatment of AK104 in combination at the RP2D.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cadonilimab	Subjects will receive AK104 by intravenous administration
BIOLOGICAL	Ivonescimab	Subjects will receive AK112 by intravenous administration
DRUG	XELOX	Subjects will receive AK104 and AK112 in combination with XELOX(oxaliplatin and capecitabine)
DRUG	SOX	Subjects will receive AK104 and AK112 in combination withSOX(oxaliplatin and Tegafur)

Timeline

• Start date: 2024-04-10
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2024-01-09
• Last updated: 2024-06-27

Locations

1 site across 1 country: China