A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma

Phase 1/2 Completed 338 enrolled Akeso Akeso Pharmaceuticals, Inc. · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, when administered as a single agent in adults subjects with advanced or metastatic solid tumors, or combined with oxaliplatin and capecitabine as first-line therapy in adult subjects with advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Timeline

Start: 2019-01-18
Primary completion: 2024-03-25
Completion: 2024-03-25

Publications

Peng J, Zhu Q, Peng Z, Chen Z, Liu Y, Liu B. Patients with positive HER-2 amplification advanced gastroesophageal junction cancer achieved complete response with combined chemotherapy of AK104/cadonilimab (PD-1/CTLA-4 bispecific): A case report. Front Immunol. 2022 Dec 8;13:1049518. doi: 10.3389/fimmu.2022.1049518. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cadonilimab	Monoclonal antibody	—	Intravenous
Subject	Capecitabine	Small molecule	1000 mg/m2	—
Subject	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous

A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma

Summary

Timeline

Publications

Drugs

Indications