A Pilot Study of 89Zr-DFO-REGN3767 Anti LAG-3 Antibody Positron Emission Tomography in Patients With Relapsed/Refractory DLBCL
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Biodistribution of 89Zr-DFO-REGN3767
研究概览
简要总结
The main purposes of this study include:
Looking at the way the body absorbs, distributes, and gets rid of 89Zr-DFO-REGN3767
Finding the best dose amount of 89Zr-DFO-REGN3767
Finding the best time for PET scanning after injection of 89Zr-DFO-REGN3767
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- •A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, meet the following criteria to be eligible for inclusion in the study:
- •Measurable disease by Lugano criteria, with at least one lesion outside of the liver
- •Patients must have eGFR >50 mL/min/1.73m2.
排除标准
- •A patient must be eligible for DLBCL expansion cohort 9 in study 17-421 and, in addition, a patient who meets any of the following criteria will be excluded from the study:
- •Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.
- •Has not yet recovered (i.e. ≤ Grade 1 or baseline) from any acute toxicities from prior anticancer therapy except for laboratory changes as described in inclusion criteria in study 17-421, except as noted. NOTE: Patients with chronic or stable toxicity following approved therapy, such as mild persistent neuropathy, are allowed.
- •Has received radiation therapy within 14 days of first administration of study drug or has not recovered (i.e. ≤ Grade 1 or baseline) from adverse events, except for laboratory changes as described in inclusion criteria, except as noted. NOTE: Patients with chronic or stable toxicity, such as mild persistent neuropathy, are allowed.
- •Women who are pregnant, breastfeeding *Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Pregnancy testing and screening will be performed per MSK and Department of Radiology standard pregnancy screening guidelines.
研究组 & 干预措施
Cohort 1
Up to 3 participants will be enrolled to receive a single dose of 89Zr-DFO-REGN3767 (total 2mg antibody mass). Participant to undergo 3 PET/CT scans and concurrent blood draws for PK
干预措施: 89Zr-DFO-REGN3767 (Drug)
Cohort 1
Up to 3 participants will be enrolled to receive a single dose of 89Zr-DFO-REGN3767 (total 2mg antibody mass). Participant to undergo 3 PET/CT scans and concurrent blood draws for PK
干预措施: PET/CT (Diagnostic Test)
Cohort 2
Up to 3 participants will be enrolled to receive a total 5mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: 89Zr-DFO-REGN3767 (Drug)
Cohort 2
Up to 3 participants will be enrolled to receive a total 5mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: PET/CT (Diagnostic Test)
Cohort 3
Up to 3 participants will be enrolled to receive a total 10mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: 89Zr-DFO-REGN3767 (Drug)
Cohort 3
Up to 3 participants will be enrolled to receive a total 10mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: PET/CT (Diagnostic Test)
Cohort 4
Up to 3 participants will be enrolled to receive a total 20mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: 89Zr-DFO-REGN3767 (Drug)
Cohort 4
Up to 3 participants will be enrolled to receive a total 20mg of 89Zr-DFO-REGN3767 (+REGN3767) total antibody mass for PK and serial imaging with 3 PET/CT scans
干预措施: PET/CT (Diagnostic Test)
结局指标
主要结局
Biodistribution of 89Zr-DFO-REGN3767
时间窗: 2 years
A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution of 89Zr-DFO-REGN3767
Optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
时间窗: 2 years
Determine the optimal 89Zr-DFO-REGN3767 mass dose for tumor targeting
Optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
时间窗: 2 years
Determine the optimal time for imaging and tumor uptake post 89Zr-DFO-REGN3767 administration
Tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC
时间窗: 2 years
Evaluate tumor lesion uptake of 89Zr-DFO-REGN3767 and correlate with LAG-3 expression by IHC in tumors will be compared descriptively with other biomarkers of tumor immune environment characterized in biopsies, such as quantitation of IHC score (LAG-3 and / or other immune cell markers), or other biomarker measures.
次要结局
未报告次要终点