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Safety and Efficacy of Yiwoxidan Anti (AK112) Monotherapy in Patients With Metastatic Renal Clear Cell Carcinoma Who Are Intolerant to TKI Treatment: a Prospective, Single Arm, Phase II Clinical Study

Sponsor: Sun Yat-sen University

Summary

This study is testing a new medicine called AK112 (Yivoximab) for people with advanced kidney cancer that has spread to other parts of the body (metastatic clear cell renal cell carcinoma). AK112 is a special kind of drug called a dual-target antibody that works in two ways: it helps the immune system fight cancer and blocks blood vessels that feed the tumor. The goal of this study is to see how well AK112 works as a first-line treatment (before any other treatment) and how safe it is. We will look at how many patients' tumors shrink or stop growing, how long they live without their disease getting worse, and whether they have side effects. This is a Phase II, single-arm, open-label study, meaning all participants will receive AK112, and everyone involved knows what treatment is being given. The study will take place at multiple hospitals across China and will include about 60 patients aged 18 to 75 years who have not received prior systemic treatment for advanced kidney cancer. Participants will receive AK112 through an IV infusion every three weeks until the cancer progresses or side effects become too severe. They will have regular check-ups, including blood tests, imaging scans (like CT or MRI), and physical exams to monitor their health and response to treatment. The study is expected to start in November 2023 and end in June 2027. Participation is voluntary, and all medical care related to the study will be provided at no cost. Participants may also be covered by clinical trial insurance in case of unexpected harm. We hope this study will help find a better treatment option for people with advanced kidney cancer.

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