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New treatment option for Ewing Sarcoma
Official title A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
ClinicalTrials.gov ID: NCT06564272
What this study is testing
What is KC1036?
KC1036 is an investigational medicine, given as an once-daily, being studied as a potential treatment for ewing sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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...
- Body weight of ≥30 kg;
- Karnofsky performance status (≥16 years) or Lansky performance status (\<16 years) score of ≥60%;
You likely can't join if
- Patients with primary central nervous system tumors;
- Presence of central nervous system metastases as diagnosed by imaging;
- History of or concurrent other malignancies within the past 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular or cerebrovascular abnormalities;
- Patients who have previously received VEGFR-TKI small molecule treatment;
See the full eligibility criteria
- 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.
- Patients with primary central nervous system tumors;
- Presence of central nervous system metastases as diagnosed by imaging;
- History of or concurrent other malignancies within the past 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular or cerebrovascular abnormalities;
- Patients who have previously received VEGFR-TKI small molecule treatment;
- Currently participating in another therapeutic clinical trial; received any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) before the start of the study treatment; received whole-brain...
- Underwent major surgery within 2 months before enrollment or have not fully recovered, or plan to undergo surgery during the current study period;
- Persistent toxicity from previous anticancer treatment that has not improved to ≤ Grade 1 (according to CTCAE v5.0), excluding alopecia;
- Unhealed skin wounds, surgical sites, traumatic sites, severe mucosal ulcers, or fractures;
- Uncontrolled significant pleural effusion, ascites, or pericardial effusion;
- Active bacterial, viral, or fungal infections; unexplained fever \>38.5°C within 2 weeks before enrollment;
- Hepatitis B surface antigen (HBsAg) positive with HBV-DNA ≥500 IU/mL or 2500 copies/mL; Hepatitis C virus (HCV) antibody positive with HCV RNA ≥200 IU/mL or positive test results; HIV-positive individuals;
- Presence of psychiatric or neurological disorders; or cognitive impairment;
- Fertile patients (e.g., females who have started menstruating or males who have started ejaculating) who do not agree to use contraception (e.g., birth control pills or condoms) during the study and for 6 months after...
- Patients with insufficient compliance as evaluated by investigator;
- The investigator believes that it is not suitable to patient in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.