Evaluating KC1036 for treating advanced Ewing sarcoma in adolescents

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

This study is testing a new treatment called KC1036 to see if it can help teenagers with advanced Ewing sarcoma who have run out of other treatment options.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06564272 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm clinical trial aims to assess the safety and effectiveness of KC1036 in adolescents aged 12 to 18 with advanced Ewing sarcoma. Participants will receive KC1036 once daily, with treatment cycles lasting four weeks. The study focuses on patients with unresectable or metastatic Ewing sarcoma who have exhausted standard treatment options. The trial will monitor the participants for measurable responses and overall health during the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 18 diagnosed with advanced Ewing sarcoma that is unresectable or has failed standard treatments.

Not a fit: Patients with primary central nervous system tumors or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for adolescents with advanced Ewing sarcoma who have limited alternatives.

How similar studies have performed: While this approach is novel for this specific treatment, similar studies targeting advanced Ewing sarcoma have shown varying degrees of success.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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 radiation therapy within 14 days before the start of the study treatment; received stereotactic radiosurgery within 7 days before the start of the study treatment; or received herbal or traditional Chinese medicine for anticancer purposes within 2 weeks before the study treatment;
* 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 the study ends;
* Patients with insufficient compliance as evaluated by investigator;
* The investigator believes that it is not suitable to patient in this clinical trial.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Children's Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Huanmin Wang — Beijing Children's Hospital Affiliated to Capital Medical University
• Study coordinator: Xin Ni

Conditions Ewing Sarcoma