NCT06564272招募中2 期
A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
KC1036
Experimental
oral administration QD
干预措施: KC1036 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: approximately 3 years
Incidence of treatment-related AEs
次要结局
- Objective Response Rate (ORR)(approximately 3 years)
- Progression-free survival (PFS)(approximately 3 years)
- Disease Control Rate (DCR)(approximately 3 years)
- Duration of Response (DOR)(approximately 3 years)
研究者
研究点 (1)
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