A First-in-Human Study of 89Zr-DFO-REGN5054 (Anti-CD8) Positron Emission Tomography in Patients With Solid Malignancies Treated With Cemiplimab
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This study is researching an experimental drug called 89Zr-DFO-REGN5054 and cemiplimab. The study is focused on patients with a type of cancer that can be potentially imaged using 89Zr-DFO-REGN5054 and show special tumor features that may be important to the way the immune system fights cancer.
The aim of the study is to study the safety and tolerability (how the body reacts to the drug) of the imaging agent 89Zr-DFO REGN5054.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy
- •Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Adequate organ and bone marrow function as defined in the protocol
- •Willing and able to comply with clinic visits and study-related procedures (including required tumor biopsy for Part B)
排除标准
- •Currently receiving another cancer treatment or inadequate time since last therapy, as defined in the protocol
- •Has not yet recovered from acute toxicities from prior therapy; exceptions defined in the protocol
- •Prior treatment with a blocker of the PD-1/Programmed death ligand 1 (PD-L1) pathway
- •Currently receiving or has received chimeric antigen receptor (CAR-T) cell therapy
- •Symptomatic or untreated brain metastases, leptomeningeal disease, or spinal cord compression
- •Known history of or any evidence of interstitial lung disease, active, noninfectious pneumonitis (past 5 years) or active tuberculosis
- •NOTE: Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part A:
Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
干预措施: 89Zr˗DFO˗REGN5054 (Drug)
Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part A:
Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment.
干预措施: cemiplimab (Drug)
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part B:
Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
干预措施: 89Zr˗DFO˗REGN5054 (Drug)
Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab
Part B:
Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A.
干预措施: cemiplimab (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: Up to day 8, after the infusion of 89Zr˗DFO˗REGN5054
Part A
Incidence and severity of TEAEs
时间窗: Up to approximately week 115
Part A and B
次要结局
- Concentration of 89Zr-DFO-REGN5054 in serum(On days 1, 5 and 8)
- Serum imaging agent activity concentration of area under the curve (AUC0-7)(Up to day 8)
- Blood pool uptake of 89Zr-DFO-REGN5054 with subsequent calculation of standardized uptake value (SUV) tumor-to-blood ratios(At the time of imaging, up to day 8)
- 89Zr-DFO-REGN5054 uptake across cluster of differentiation 8 (CD8)-expressing normal tissues and tumors(At the time of imaging, up to day 8)
- Association of 89Zr˗DFO˗REGN5054 autoradiographic signal intensity distribution with CD8 expression in tumor tissues(At Baseline)
- Association of tumor-to-blood ratio of 89Zr-DFO-REGN5054 with CD8 expression in tumor tissues(At Baseline)
- Clinical dosimetry based on tissue radiation effective dose calculated from PET image acquisition data(On days 1, 5 and 8)
- Clinical dosimetry based on tissue radiation absorbed dose calculated from positron emission tomography (PET) image acquisition data(On days 1, 5 and 8)
- Association of 89Zr-DFO-REGN5054 uptake with CD8 expression in tumor tissues(At Baseline)