EUCTR2017-000238-73-ES进行中（未招募）1 期
A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 (anti-ICOS mAb) Alone or in Combination with Nivolumab or Ipilimumab in Patients with Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •_Advanced solid tumors;
- •_Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
- •_At least 1 lesion accessible for biopsy in addition to the target lesion;
- •_Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen;
- •_Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 94
排除标准
- •_Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll);
- •_Participants with carcinomatous meningitis;
- •_Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in
- •situ of the prostate, cervix, or breast;
- •_Active, known, or suspected autoimmune disease;
- •_Uncontrolled or significant cardiovascular disease.
研究者
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