A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 15
- 主要终点
- Changes in GGT (U/L) Laboratory Values Compared With Baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Up to 1 week prior to initiation of immunotherapy, patients will receive an injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and will undergo PET/CT scanning to determine baseline uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues. Patients will receive an additional injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and PET/CT scan 4-6 weeks after starting immunotherapy (on-therapy) to evaluate uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues, and to assess potential changes in uptake of ⁸⁹Zr-Df-IAB22M2C compared to the baseline scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- •Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.
- •At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
- •At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.
- •Age ≥ 18 years.
- •Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
- •Willingness and ability to comply with all protocol required procedures.
- •For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
排除标准
- •Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- •Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- •Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
- •Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- •Pregnant women or nursing mothers.
- •Life expectancy < 6 months
研究组 & 干预措施
⁸⁹Zr-Df-IAB22M2C Infusion
A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT.
干预措施: ⁸⁹Zr-Df-IAB22M2C (Drug)
结局指标
主要结局
Changes in GGT (U/L) Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
GGT (U/L) laboratory values compared with baseline results.
Diastolic Blood Pressure
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Diastolic Blood Pressure
Number of Participants With Adverse Events
时间窗: Up to 12 weeks
Number of participants who experienced any treatment emergent adverse events
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
hemoglobin (g/dL) laboratory values compared with baseline results.
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
serum creatinine (mg/dL) laboratory values compared with baseline results.
Total Bilirubin (mg/dL) Laboratory Values
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Total bilirubin (mg/dL) laboratory values compared with baseline results.
Participants With Signs and Symptoms of Infusion Reactions
时间窗: Up to 12 weeks
Number of participants with reported signs or symptoms of infusion reactions
Change in WBC Absolute Counts
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
WBC absolute counts
Changes in Platelet Count Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
platelet count laboratory values compared with baseline results.
Changes in WBC Count Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
WBC count laboratory values compared with baseline results.
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
blood glucose (mg/dL) laboratory values compared with baseline results.
Changes in Potassium Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Potassium laboratory values compared with baseline results.
Changes in Chloride Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
chloride laboratory values compared with baseline results.
Changes in LDH (U/L) Laboratory Values Comapared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
LDH (U/L) laboratory values compared with baseline results.
PR Interval Assessed by 12-Lead Electrocardiogram
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
PR interval reported in milliseconds (msecs)
Evaluation of Heart Rate (Beats Per Minute)
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in heart rate
QT Interval Assessed by 12-Lead Electrocardiogram
时间窗: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
QT interval reported in milliseconds (msec)
Changes in RBC Count Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
RBC count laboratory values compared with baseline results.
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
BUN (mg/dL) laboratory values compared with baseline results.
ALP Laboratory Values
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in ALP (U/L) laboratory values compared with baseline results.
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)
时间窗: Baseline to 4-5 weeks after the start of immunotherapy
Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean, CD8 tumor volume, and tumor:reference tissue ratio) with CD8+ cell measurement determined by IHC from biopsy samples.
Changes in Hematocrit (%) Laboratory Values
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
hematocrit (%) laboratory values
Changes in Sodium Laboratory Values Compared With Baseline
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
sodium laboratory values compared with baseline results.
ALT Laboratory Values
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in ALT (U/L) laboratory values compared with baseline results.
Evaluation of Respiration Rate
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in respiration rate
AST Laboratory Values
时间窗: Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Change/shifts in AST (U/L) laboratory values compared with baseline results.
Evaluation of Temperature
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Changes/shifts in temperature
QRS Interval Assessed by 12-Lead Electrocardiogram
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QRS Interval reported in milliseconds (msec)
QTc Interval Assessed by 12-Lead Electrocardiogram
时间窗: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QTc interval reported in milliseconds (msecs)
次要结局
- Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations(5 weeks)
- Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis(7 weeks)
- Description of Biodistribution Patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and Any Changes in Biodistribution Between Baseline and On-Treatment.(7 weeks)