Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery
A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery
研究概览
详细说明
Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.
This is a two part study:
Part 1 - Dose Finding: Subjects will be required to arrive at the phase 1 unit for dosing 2-3 days prior to the planned surgical excision. Two dose levels of BLZ-100 (3 mg and 12 mg) will be evaluated in a total of 6 subjects with a 2-3 day post-dose imaging interval (also defined as the Intermediate Imaging interval).
Part 2 - Imaging Interval Assessment: The BLZ-100 dose to be evaluated in Part 2 will be determined by the Protocol Steering Committee following completion of Part 1. In Part 2, up to 15 additional subjects will be randomized into one of three imaging interval groups (up to 6 subjects per group): Early Imaging (within 1 day post BLZ-100 dose), Intermediate Imaging (2-3 days post BLZ-100 dose), and Late Imaging (4-7 days post BLZ-100 dose). Subjects will be required to arrive at the phase 1 unit for dosing between 1 and 7 days prior to planned surgical excision, depending on which imaging interval they are randomized to.
Following dosing, all subjects will be monitored for safety.
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male of female subject aged 18-75 years
- Diagnosis of soft tissue sarcoma, with scheduled surgical removal for treatment for the disease and completion of chemotherapy or radiation within 4 weeks of BLZ-100 administration
- Able to provide written informed consent
- If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration
- Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
- Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor [PNET])
- Evidence of metastatic disease
- Female who is lactating/breastfeeding
- Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study
- Karnofsky Performance Status of <60%
Any of the following laboratory abnormalities at Screening:
- Neutrophil count <1.5 x 10^9/L
- Platelets <75 x 10^9/L
- Hemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3x upper limit of normal (ULN)
- Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- Internal Normalized Ratio (INR) >1.5
- Creatinine >1.5x ULN
- Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
- QTc prolongation >450 msec
- History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization
- Uncontrolled asthma or asthma requiring oral corticosteroids
- Known or suspected sensitivity to imaging agents that may be used in clinical assessment of this study
- Known or suspected sensitivity to indocyanine green (ICG)
- Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening
- Uncontrolled hypertension
- Initiation of new photosensitizing drugs within 30 days of Screening
- Use of any ongoing medications, which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix
- Receipt of an investigational drug or device within 30 days of enrollment
- Prior administration of BLZ-100
- Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：BLZ-100
All participants in the study will receive the investigational drug product BLZ-100. In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window. In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose). |
All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors. Three different imaging windows will be investigated during the study: Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose) All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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发生不良事件的参与者人数
大体时间：研究药物给药后 7 天
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将通过体格检查和生命体征测量以及实验室安全参数来评估安全性。
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研究药物给药后 7 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of concentration of BLZ-100 in the blood
大体时间：Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
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BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
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Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery
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Fluorescence signal from areas of tumor and non-tumor
大体时间：1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
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Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
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1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
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Ideal combination of dose and imaging interval
大体时间：1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
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Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.
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1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
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合作者和调查者
调查人员
- 首席研究员：Charles Forscher, MD、Cedars-Sinai Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
BLZ-100的临床试验
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Blaze Bioscience Inc.Pacific Pediatric Neuro-Oncology Consortium完全的
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University of WashingtonBlaze Bioscience Inc.终止III 期唇癌和口腔癌 AJCC v8 | 口腔鳞状细胞癌 | I 期唇部和口腔癌 AJCC v8 | II 期唇部和口腔癌 AJCC v8 | IVA 期唇部和口腔癌 AJCC v8美国