A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma
This open-label, single-arm clinical trial is to evaluate the safety and effectiveness of KC1036 in treating adolescents aged 12 and above with advanced Ewing sarcoma. Participants will take KC1036 once daily, with each treatment cycle lasting 4 weeks.
• Age between 12 and less than 18 years;
• Diagnosed with Ewing sarcoma confirmed by histopathological examination;
• Patients with locally advanced or metastatic Ewing sarcoma that is unresectable or has failed standard treatment, and for whom no other treatment options are available as assessed by the investigator;
• Body weight of ≥30 kg;
• Karnofsky performance status (≥16 years) or Lansky performance status (\<16 years) score of ≥60%;
• Patients with at least one measurable lesions according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors);
• Expected survival of more than 12 weeks;
• Sufficient organ and bone marrow function;
• Female patients who have started menstruating must have a negative pregnancy test;
• The patient and their legal guardians understand and are willing to participate in the trial, and have signed the informed consent form.