CTIS2023-504012-16-00招募中1 期
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer - TAK-280-1501
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 129
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •01. Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable., 02. Criteria for disease state in dose escalation and cohort expansion. a. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers. b. Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms., 03. Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1., 04. Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was = 6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.
排除标准
- •01. History of known autoimmune disease., 02. Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280., 03. Unhealed wounds from surgery or injury., 04. Ongoing or active infection of Grade >=2., 05. Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment., 06. Inflammatory process that has not resolved for >= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration., 07. Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug. Inactivated annual influenza vaccination is allowed., 08. Known hypersensitivity to TAK-280 or any excipient.
研究者
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