The Phase I Clinical Trial Unit of Peking University Cancer Hospital was established in 2014, making it one of the earliest clinical centers in China dedicated to advancing the early-stage development of innovative anti-tumor drugs. This unit is committed to accelerating the clinical development of novel anti-tumor therapies and driving disciplinary growth through clinical research. The Phase I Clinical Trial Unit is equipped with 15 routine inpatient beds and offers 5 outpatient clinic sessions per week. With strong professional expertise, the unit manages over 200 early-phase clinical studies and has treated more than 10,000 patients from across the country. It has facilitated the approval and market launch of several innovative anti-tumor drugs, including Disitamab Vedotin, Envafolimab, and Sugemalimab. The unit possesses extensive clinical trial experience in novel anti-tumor therapies such as cell therapy, small interfering RNA (siRNA) drugs, and oncolytic viruses, ranking at the national forefront. Additionally, the professional nursing team in this unit holds GCP qualifications and basic emergency rescue skills, ensuring comprehensive safety for patients throughout the process. The department comprises 2 chief physicians, 2 associate chief physicians, 1 associate researcher, 4 attending physicians, 1 doctoral supervisor, and 1 master's supervisor. Research findings have been published in top-tier international journals such as *The Lancet*, *Nature Medicine*, and *Journal of Clinical Oncology*. The unit also undertakes multiple key projects funded by national programs, the Ministry of Science and Technology, and the former Medical Administration Bureau, and has established collaborations with several national key research institutions. Through multidisciplinary and cross-field efforts, it comprehensively promotes the steady development of early-stage research on novel anti-tumor drugs. Our team consistently adheres to a patient-centered approach, continuously optimizing and innovating around the key aspects of clinical research on anti-tumor drugs. We have established a complete research system spanning from target screening and preclinical evaluation to early-phase clinical trials. Leveraging the hospital's robust multidisciplinary collaboration platform, we have built standardized biobanks and data management systems, laying a solid foundation for subsequent translational outcomes and accelerating the advancement of China's independently developed innovative drugs toward international standards.