This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.~The research adopts the Simon two-stage design method, which is carried out in two stages.~The first stage:~In the first phase, a single-arm, open, multi-center study was adopted, and YY-20394 monotherapy was given to patients who met the enrollment conditions. The trial enrolled 18 subjects. If ≥2 subjects had ORR (clinical benefit), then enter the second phase, otherwise the trial will be terminated.~The second stage:~Refer to the efficacy data of the first phase to decide whether to conduct the second phase of clinical research.~In the second phase, a single-arm, open, multi-center study was adopted. Patients who met the enrollment conditions were given YY-20394 monotherapy. In the second phase, 40 subjects will continue to be enrolled.~A total of 58 subjects were included in the two stages. During the study period, the investigator judged the best curative effect of all subjects according to the response evaluation criteria in solid tumours (Response evaluation criteria in solid tumours, RECIST 1.1). IRC will use the same standards to evaluate the efficacy of the imaging results of all subjects, and the entire review process will be conducted in accordance with an independent review procedure. The Research Safety Monitoring Committee (SMC) will continue to review the safety of study drugs. SMC will be responsible for monitoring safety data and making decisions on research-related issues, such as study enrollment, dose selection, whether to continue the study, etc.
This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.~The research adopts the Simon two-stage design method, which is carried out in two stages.