RecruitingPhase 2NCT06564272

A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma

A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma


Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Enrollment

30 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called KC1036 in teenagers aged 12–17 with Ewing sarcoma — a type of bone and soft tissue cancer — that is advanced, has spread, or has failed standard treatments. **You may be eligible if...** - You are between 12 and 17 years old - You have a confirmed diagnosis of Ewing sarcoma - Your cancer is advanced, has spread, or has not responded to standard treatment options - You weigh at least 30 kg (about 66 pounds) - You are in reasonable general health (performance score of 60% or higher) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have a primary brain tumor or brain metastases - You have had another cancer in the past 5 years - You have had prior treatment with a VEGFR-targeted small molecule drug - You have significant heart, gut, or brain blood vessel problems - You are currently in another therapeutic clinical trial - You are pregnant (for female patients who have started menstruating) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKC1036

For patients weighing between 30 kg and less than 50 kg, administer 40 mg QD of KC1036. For patients weighing between 50 kg and less than 70 kg, administer 50 mg QD of KC1036. For patients weighing 70 kg or more, administer 60 mg QD of KC1036. 4 weeks as a cycle.


Locations(1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

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NCT06564272


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