NCT06816108进行中（未招募）1 期
A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors
Ono Pharmaceutical Co., Ltd.15 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年4月21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
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 15
- 主要终点
- Adverse event (AE)
研究概览
简要总结
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- •[Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.
- •Participants who are refractory or intolerant to standard therapy.
- •Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
- •Participants with Eastern Cooperative Oncology Group Performance Status 0 or
- •Participants with tumor tissue samples available for biomarker testing.
排除标准
- •Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
- •Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- •Participants with severe peritoneal dissemination.
- •Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
- •Participants with uncontrolled tumor-related pain.
- •Participants with active or history of interstitial lung disease or pulmonary fibrosis.
研究组 & 干预措施
ONO-7428
Experimental
干预措施: ONO-7428 (Drug)
结局指标
主要结局
Adverse event (AE)
时间窗: Up to 2 years
Dose-limiting toxicities（DLT）
时间窗: 21 days
次要结局
- Ctrough(Up to 2 years)
- Percent change from baseline in the sum of diameters of target lesions(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Area under the Plasma Concentration versus Time Curve (AUC)(Up to 2 years)
- Cmax(Up to 2 years)
- Tmax(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Best reduction percent change from baseline in the sum of diameters of target lesions(Up to 2 years)
- Best Overall Response (BOR)(Up to 2 years)
研究者
研究点 (15)
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