Phase IaIb Study of AK127 and AK104 Combination Therapy for Advanced Malignant Tumors Evaluating Safety, Tolerability, and Early Effectiveness

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of two drugs, AK127 and AK104, combined for treating patients with advanced malignant tumors. This Phase IaIb open-label clinical trial focuses on patients whose cancer has progressed despite previous treatments or who are not suitable for standard therapies. The study aims to explore how blocking multiple immune checkpoints simultaneously may improve the bodys anti-tumor response. The study includes two main stages a dose escalation phase with five dose groups of AK127 given every three weeks at increasing doses alongside a fixed dose of AK104, and a dose expansion phase with several patient cohorts representing different tumor types. Both drugs are administered intravenously every three weeks. The trial assesses the combined effect of AK127, a monoclonal antibody targeting TIGIT, and AK104, a bispecific antibody targeting PD-1 and CTLA-4, to potentially enhance immune system activity against tumors. Participants will receive the study drugs intravenously and undergo regular monitoring for up to approximately two years. Researchers will evaluate safety through the frequency and severity of adverse events, including immune-related side effects, and study the drugs behavior in the body. Effectiveness will be measured by tumor response rates, disease control, survival outcomes, and other pharmacokinetic parameters. The study includes physical exams, laboratory tests, imaging, and ongoing safety assessments throughout the participation period.

A Phase Ia/Ib Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors