An Open Label, Multicentre, Positron Emission Tomography (PET) Imaging Study Using Zirconium-89 to Investigate the Biodistribution and Tumour Uptake of a PD-L1x4-1BB Bispecific Antibody (S095012) in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in PET/CT scan images
研究概览
简要总结
The purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89Zr-S095012 in participants with solid tumours treated with S095012 (PD-L1x4-1BB bispecific antibody)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated
- •At least one measurable target lesion as per RECIST 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis)
- •Adequate organ function as assessed by laboratory tests (especially adequate hepatic function)
- •Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards.
排除标准
- •Participants with no available archived material and no tumour lesions amenable to biopsy
- •Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis
- •Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent)
- •Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded.
- •Participants who received either systemic corticosteroids (> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded.
- •Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis
- •Participants with a history of progressive multifocal leukoencephalopathy
- •Participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
研究组 & 干预措施
89Zr-S095012 tracer with S095012
干预措施: 89Zr-S095012 tracer and S095012 will be administered via an IV infusion (Drug)
结局指标
主要结局
Change in PET/CT scan images
时间窗: Within 14 days following the tracer injection and baseline (before the first treatment administration)
Visual analysis of target lesions
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
时间窗: Up to 8 days following first treatment administration
Standardised uptake value (SUV)
Serum PK parameters of 89Zr-S095012 during the range finding period (Part A)
时间窗: radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration (during the dose ranging period)
Area under the curve (AUC)
Serum PK parameters of 89Zr-S095012 at baseline (Part B)
时间窗: radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration
Area under the curve (AUC)
Change in Comparison of 89Zr-S095012 tumour uptake (as described using Standardised Uptake Value and concentrations) before and on treatment with different doses of S095012.
时间窗: In Part C (imaging period 2) between Day 1 and Day 8 of cycle 1 (the duration of cycle 1 is 28 days)
Number of patients discontinuing study intervention due to an adverse event
时间窗: Throughout the study up to 30 days after the last IMP for all AEs, or up to 90 days for all AEs related to the IMP and death
PET/CT scan images
时间窗: Up to 8 days following the first treatment administration
Visual analysis of target lesions
Parameters derived from PET scans for organs and tumour lesions
时间窗: Up to 8 days following first treatment administration
Volume of interest
Serum PK parameters of 89Zr-S095012 on treatment (Part C- schedule 1)
时间窗: radioactive plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day 1) and on Day 2, Day 3, Day 5 and Day 8 following the first treatment administration
Area under the curve (AUC)
Incidence and severity of adverse events
时间窗: Throughout the study up to 30 days after the last IMP for all AEs, or up to 90 days for all AEs related to the IMP and death
Change in PET/CT scan images
时间窗: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
Visual analysis of target lesions
Parameters derived from PET scans for organs and tumour lesions
时间窗: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
Change in Volume of interest
Parameters derived from PET scans for organs and tumour lesions
时间窗: Within 14 days following the tracer injection and baseline (before the first treatment administration)
Change in Volume of interest
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
时间窗: Within 14 days following the tracer injection and baseline (before the first treatment administration (during the dose range finding period))
Change in Standardised uptake value (SUV)
Parameters derived from PET scan images to assess uptake in tumour lesions and normal tissues
时间窗: Within 14 days following the tracer injection and baseline ( before the first treatment administration)
Change in Standardised uptake value (SUV)
次要结局
- Serum PK parameters of S095012 at baseline (Part B)(plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration)
- Serum PK parameters of S095012 on treatment (Part C - schedule 1)(plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day 1) and on Day 2, Day 3, Day 5, Day 8 and Day 15 following the first treatment administration)
- Preliminary antitumour activity assessment of S95012(The events to be studied are Complete Response or Partial Response, from the first treatment administration up to one year (for patients with confirmed Complete response) or 2 years (for Patients with confirmed Partial Response).)
- Serum PK parameters of S095012 during the range finding period (Part A)(plasma samples taken at : 5, 30, 60, 120 minutes, 6 hours (on Day-14) and on Day-13, Day-12, Day-10 and Day-7 following the tracer injection and before the first treatment administration (during the dose ranging period))
- Organ and whole-body radiation exposure (milliSilvert per Mega Becquerel (mSv/MBq): Effective dose per organ and whole-body effective dose.(In Part A, B and C (imaging period 1) at Day-14)