Phase II Study of Daily Oral KC1036 for Adolescents Aged 12 to 18 With Advanced Ewing Sarcoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of KC1036 in adolescents aged 12 to under 18 years with advanced Ewing sarcoma, a type of cancer that is locally advanced or metastatic and has not responded to standard treatments. This open-label, single-arm Phase II clinical trial focuses on patients with no other treatment options, aiming to assess how well KC1036 works and its safety profile over approximately three years. Participants will take KC1036 orally once daily in 4-week treatment cycles. Dosage depends on body weight 40 mg daily for those weighing 30 to less than 50 kg, 50 mg daily for 50 to less than 70 kg, and 60 mg daily for 70 kg or more. The study does not involve a comparison group and continues treatment cycles as long as participants meet criteria. During the trial, participants will be monitored for adverse events and various measures of cancer response, including objective response rate, disease control rate, progression-free survival, and duration of response, over about three years. Participants will undergo regular assessments such as imaging to evaluate measurable lesions, organ function tests, and pregnancy tests when applicable. The study includes safety monitoring and requires informed consent from both patients and their legal guardians.

A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma