NL-OMON53715招募中不适用
A First-In-Human study of 89ZR-DFO-REGN5054 (anti-CD8) Positron Emission Tomography in patients with solid malignancies treated with cemiplimab - 89ZR-DFO-REGN5054 PETscan study in patient with cemiplimab treated cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
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 99（—）
入选标准
- •1.Advanced or metastatic solid tumors that may respond to anti-programmed cell
- •death 1 (PD-1) immunotherapy
- •2. Measurable disease according to Response Evaluation Criteria in Solid
- •Tumours (RECIST) 1.1 criteria
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of <=1
- •4. Adequate organ and bone marrow function as defined in the protocol
- •5. Willing and able to comply with clinic visits and study-related procedures
- •(including required tumor biopsy for Part B
- •NOTE: Other protocol defined inclusion criteria apply.
排除标准
- •1. Currently receiving another cancer treatment in another studyor inadequate
- •time since last therapy, as defined in the protocol
- •2. Has not yet recovered from acute toxicities from prior therapy; exceptions
- •defined in the protocol
- •3. Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1)
- •4. Currently receiving or has received chimeric antigen receptor (CAR-T) cell
- •5. Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal
- •cord compression
- •6. Known history of or any evidence of interstitial lung disease, active,
- •noninfectious pneumonitis (past 5 years) or active tuberculosis
- •PLEASE NOTE: ADDITIONAL EXCLUSION CRITERIA APPLY AND ARE OUTLINED IN THE
研究者
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