A Phase I Study to Assess Biodistribution of 89Zr-CB307 in PSMA+ and PSMA- Tumour Lesions (A Sub-study of CBT307-1 Study - EUDRACT 2019-004584-46)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions.
研究概览
简要总结
CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.
详细描述
Phase 1, Open-label, single centre, non-randomised study during which, enrolled patients will undergo a number of PET scans following administration of 89Zr-CB307, in order to assess the uptake of the radiolabelled drug. A post-treatment tumour biopsy for the assessment of PSMA expression will also be taken, if medically feasible, after the last PET scan.
The sub-study consists of 2 parts: an Optimisation Phase (Part A) and an Expansion Phase (Part B).
In Part A, both 89Zr-CB307 and CB307 will be administered to patients. The timing of the scans, post-dose tumour biopsy and CB307 dose will be optimised as determined by the Optimisation Review Committee (ORC).
In Part B (Expansion Phase), 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A.
The sub-study will continue for 7 days after the tracer injection. Patients will then be enrolled into the main study and will receive Cycle 1 Day 1 (C1D1) CB307 treatment according to the main study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label single center non-randomised study
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
- •Capable of understanding the written informed consent.
- •Aged at least 18 years.
- •Not amenable to standard of care.
- •ECOG PS of 0 or
- •Documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours.
- •Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastases.
- •Adequate organ function.
- •Willing to have a biopsy sample taken immediately after the last PET scan before initiation of the main study.
排除标准
- •Subjects with autoimmune disease or regular immunosuppressants.
- •Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity.
- •Has brain metastasis including leptomeningeal metastasis or primary brain tumour.
- •Has current or history of CNS disease.
- •Has known active infection.
- •Biopsy cannot be safely obtained after the last PET scan, and not provided their consent.
研究组 & 干预措施
Part A - Optimisation Phase
Following administration of 89Zr-CB307, patients will undergo PET scans The timing of the scans and CB307 dose administration will be determined by the Optimisation Review Committee (ORC)
干预措施: Radiolabelled CB307 (Drug)
Part A - Optimisation Phase
Following administration of 89Zr-CB307, patients will undergo PET scans The timing of the scans and CB307 dose administration will be determined by the Optimisation Review Committee (ORC)
干预措施: CB307 (Drug)
Part B - Expansion phase
89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC)
干预措施: Radiolabelled CB307 (Drug)
Part B - Expansion phase
89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A by the Optimisation Review Committee (ORC)
干预措施: CB307 (Drug)
结局指标
主要结局
Assessment of 89Zr-CB307 uptake by PET scan by measuring mean standardized uptake value in the tumour lesions.
时间窗: Throughout study completion, up to 8 months from first patient recruited.
SUVmean - mean standardized uptake value.
Assessment of 89Zr-CB307 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the tumour lesions.
时间窗: Throughout study completion, up to 8 months from first patient recruited.
%ID/g - percentage of injected dose per gram.
Assessment of the safety of 89Zr-CB307 by assessing incidence of adverse events following administration of 89Zr-CB307.
时间窗: Throughout study completion, up to 8 months from first patient recruited.
Incidence (frequency and severity) of adverse events following administration of 89Zr-CB307 assessed by CTCAE version 5.0
Assessment of 89Zr-CB307 uptake by PET scan by measuring maximum standardized uptake value in the tumour lesions.
时间窗: Throughout study completion, up to 8 months from first patient recruited.
SUVpeak - maximum standardized uptake value.
次要结局
未报告次要终点