NCT07734116招募中1 期
A Multicenter, Open-label, Uncontrolled Phase I/II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma, and to Evaluate the Tolerability in Pediatric Patients.
Ono Pharmaceutical Co., Ltd.12 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年8月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Adverse events meeting protocol-defined criteria for a DLT
研究概览
简要总结
This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma, and to evaluate the tolerability in pediatric patients. The objective of this study is to explore the tolerability, safety, efficacy, and pharmacokinetics of ONO-4538HSC in patients with pediatric malignant solid tumors. The other objective is to exploratively investigate the efficacy and safety of ONO-4538HSC in patients with epithelioid sarcoma.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •[Cohort of pediatric malignant solid tumor Tolerability evaluation part]
- •Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
- •Patients with radically/curatively unresectable advanced or metastatic solid tumor who are refractory to or intolerant to standard treatment or for which no standard treatment is available.
- •Patients with ECOG PS of 0 to 1
- •[Cohort of pediatric malignant solid tumor Expansion part]
- •Patients aged ≥ 12 to < 18 years at the time of signing the informed consent form (ICF)
- •Patients with unresectable tumors for whom nivolumab intravenous monotherapy is indicated in adults according to the package insert
- •Patients who have at least 1 measurable lesion per RECIST guideline
- •Patients with ECOG PS of 0 to 2
- •[Cohort of Epithelioid Sarcoma]
- •Patients aged ≥ 12 years of age at the time of signing the informed consent form (ICF). However, patients aged ≥ 12 to < 18 years may be enrolled after tolerability is confirmed in the tolerability evaluation part in the cohort of pediatric malignant solid tumor.
- •Patients who are refractory to or ineligible to at least 1 regimen of chemotherapy including doxorubicin for unresectable advanced or recurrent epithelioid sarcoma
- •Patients who have at least 1 measurable lesion per RECIST guideline
- •Patients with ECOG PS of 0 to 2
- •Life expectancy ≥ 3 months at the time of enrollment
排除标准
- •Patients with current or previous severe hypersensitivity reactions to antibody products
- •Patients with primary central nervous system tumor
- •Patients with brain or meningeal metastases. However, patients who are asymptomatic and do not require treatment can be enrolled.
- •Patients with multiple cancers
- •Patients who have previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or other therapeutic antibodies or pharmacotherapies for regulation of T cells
研究组 & 干预措施
ONO-4538HSC
Experimental
干预措施: ONO-4538HSC (Drug)
结局指标
主要结局
Adverse events meeting protocol-defined criteria for a DLT
时间窗: 28 days
Cohort of Patients with Pediatric Malignant Solid Tumor
Serious adverse events
时间窗: UP to 100 days after the last dose
Cohort of Patients with Pediatric Malignant Solid Tumor
Adverse events
时间窗: UP to 100 days after the last dose
Cohort of Patients with Pediatric Malignant Solid Tumor
Response rate (central assessment)
时间窗: Through study completion, an average of 6 months
Cohort of Epithelioid Sarcoma
次要结局
- Serum concentration of nivolumab(Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase))
- Response rate (investigator assessment)(Through study completion, an average of 6 months)
- Progression-free survival (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Disease control rate (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Duration of response (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Time to response (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Best overall response (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Maximum percent change from baseline in the sum of diameters of target lesions (central assessment and investigator assessment)(Through study completion, an average of 6 months)
- Changes in tumor markers over time(Through study completion, an average of 6 months)
- Adverse events(UP to 100 days after the last dose)
研究者
研究点 (12)
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