跳至主要内容
临床试验/jRCT2031240647
jRCT2031240647招募中不适用

ONO-7428-01: 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.,LTD0 个研究点目标入组 60 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

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.

结局指标

主要结局

-

Tolerability, safety

次要结局

未报告次要终点

研究者

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