HONG KONG, July 14, 2026
Akeso, Inc. has announced the launch of a Phase II clinical trial in the United States evaluating a cadonilimab-based combination regimen for the perioperative treatment of locally advanced, resectable HER2-negative gastric and gastroesophageal junction (GEJ) adenocarcinoma. The study is being conducted in collaboration with the internationally renowned Memorial Sloan Kettering Cancer Center (MSKCC) and is led by Dr. Yelena Janjigian, a globally recognized expert in gastrointestinal oncology. The trial is now actively enrolling patients across the United States and is designed to generate the clinical evidence needed to support a future international multicenter Phase III study. Cadonilimab, the world’s first approved PD-1/CTLA-4 bispecific antibody, represents one of Akeso’s flagship immuno-oncology therapies and has demonstrated encouraging efficacy across multiple pivotal studies. The launch of this U.S.-based Phase II trial marks another significant milestone in Akeso’s strategy to expand the global clinical development of its innovative IO 2.0 immunotherapy platform while addressing the persistent unmet need for more effective treatments in gastric cancer.
Phase II Study Targets Improved Outcomes in Gastric Cancer
The newly initiated Phase II trial will evaluate cadonilimab in combination with perioperative therapy for patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma, one of the world’s most aggressive gastrointestinal malignancies. Despite advances in treatment, current perioperative FLOT chemotherapy, even when combined with PD-1 inhibitors, delivers limited pathologic complete response (pCR) rates and leaves a substantial proportion of patients experiencing disease recurrence within two years. Previous attempts to combine conventional PD-1 and CTLA-4 inhibitors have often been restricted by overlapping toxicities and increased treatment-related complications. By utilizing cadonilimab’s unique bispecific PD-1/CTLA-4 mechanism, researchers aim to enhance antitumor immune responses while maintaining a more favorable safety profile. The study builds upon strong clinical evidence generated from the Phase III COMPASSION-15 trial and earlier Phase II neoadjuvant studies, providing a robust scientific foundation for advancing the therapy into larger international registrational trials.
Cadonilimab Expands Global Immuno-Oncology Development
As the world’s first approved PD-1/CTLA-4 bispecific antibody, cadonilimab has emerged as one of the leading next-generation immunotherapies in oncology. The therapy has demonstrated broad clinical activity across multiple cancer types and is currently being evaluated in more than 12 registrational and Phase III clinical studies worldwide, including several international multicenter trials. Alongside ivonescimab, another first-in-class bispecific antibody developed by Akeso, cadonilimab represents the company’s IO 2.0 strategy, which seeks to improve treatment efficacy through innovative dual-target immune checkpoint modulation. Beyond gastric cancer, Akeso continues expanding the therapy’s global development through collaborations with leading academic institutions and biotechnology partners, including ongoing research exploring novel combination regimens for glioblastoma and other difficult-to-treat malignancies. These efforts reinforce cadonilimab’s growing international recognition as a potential backbone immunotherapy for future combination treatment strategies.
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Strategic Collaboration Reinforces Akeso’s Global Oncology Vision
The collaboration with Memorial Sloan Kettering Cancer Center, one of the world’s foremost cancer research institutions, underscores Akeso’s commitment to accelerating the international development of its innovative oncology pipeline. With more than 50 investigational assets, including numerous bispecific antibodies, antibody-drug conjugates (ADCs), T-cell engagers, and RNA therapeutics, Akeso continues strengthening its position as a leading global biopharmaceutical innovator. The initiation of this U.S. Phase II study reflects the company’s broader strategy of combining advanced antibody engineering with international clinical collaborations to deliver transformative therapies for patients facing cancers with limited treatment options. As enrollment progresses and additional clinical evidence emerges, the cadonilimab program has the potential to redefine perioperative treatment for gastric and gastroesophageal junction cancers, supporting the future development of more effective, precision-based immunotherapy regimens for patients worldwide.
Source: Akeso press release
