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

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Trial Identification

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

Official Title: 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

Study ID: NCT06196697

Conditions

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Interventions

Study Description

Brief 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.