A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
- Conditions
- Ewing Sarcoma
- Registration Number
- NCT06564272
- Lead Sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> - Age between 12 and less than 18 years;<br><br> - Diagnosed with Ewing sarcoma confirmed by histopathological examination;<br><br> - Patients with locally advanced or metastatic Ewing sarcoma that is unresectable or<br> has failed standard treatment, and for whom no other treatment options are available<br> as assessed by the investigator;<br><br> - Body weight of =30 kg;<br><br> - Karnofsky performance status (=16 years) or Lansky performance status (<16 years)<br> score of =60%;<br><br> - Patients with at least one measurable lesions according to RECIST v1.1 (Response<br> Evaluation Criteria in Solid Tumors);<br><br> - Expected survival of more than 12 weeks;<br><br> - Sufficient organ and bone marrow function;<br><br> - Female patients who have started menstruating must have a negative pregnancy test;<br><br> - The patient and their legal guardians understand and are willing to participate in<br> the trial, and have signed the informed consent form.<br><br>Exclusion Criteria:<br><br> - Patients with primary central nervous system tumors;<br><br> - Presence of central nervous system metastases as diagnosed by imaging;<br><br> - History of or concurrent other malignancies within the past 5 years;<br><br> - Gastrointestinal abnormalities;<br><br> - Cardiovascular or cerebrovascular abnormalities;<br><br> - Patients who have previously received VEGFR-TKI small molecule treatment;<br><br> - Currently participating in another therapeutic clinical trial; received any<br> anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) before the<br> start of the study treatment; received whole-brain radiation therapy within 14 days<br> before the start of the study treatment; received stereotactic radiosurgery within 7<br> days before the start of the study treatment; or received herbal or traditional<br> Chinese medicine for anticancer purposes within 2 weeks before the study treatment;<br><br> - Underwent major surgery within 2 months before enrollment or have not fully<br> recovered, or plan to undergo surgery during the current study period;<br><br> - Persistent toxicity from previous anticancer treatment that has not improved to =<br> Grade 1 (according to CTCAE v5.0), excluding alopecia;<br><br> - Unhealed skin wounds, surgical sites, traumatic sites, severe mucosal ulcers, or<br> fractures;<br><br> - Uncontrolled significant pleural effusion, ascites, or pericardial effusion;<br><br> - Active bacterial, viral, or fungal infections; unexplained fever >38.5°C within 2<br> weeks before enrollment;<br><br> - Hepatitis B surface antigen (HBsAg) positive with HBV-DNA =500 IU/mL or 2500<br> copies/mL; Hepatitis C virus (HCV) antibody positive with HCV RNA =200 IU/mL or<br> positive test results; HIV-positive individuals;<br><br> - Presence of psychiatric or neurological disorders; or cognitive impairment;<br><br> - Fertile patients (e.g., females who have started menstruating or males who have<br> started ejaculating) who do not agree to use contraception (e.g., birth control<br> pills or condoms) during the study and for 6 months after the study ends;<br><br> - Patients with insufficient compliance as evaluated by investigator;<br><br> - The investigator believes that it is not suitable to patient in this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events (AEs)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR);Progression-free survival (PFS);Disease Control Rate (DCR);Duration of Response (DOR)