A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery
概览
- 阶段
- 1 期
- 干预措施
- BLZ-100
- 疾病 / 适应症
- Tumors, Breast
- 发起方
- Blaze Bioscience Inc.
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
- 状态
- 已完成
- 最后更新
- 8年前
概览
简要总结
Surgery is the primary treatment modality for many types of cancer and the extent of surgical resection is directly related to patient survival. However, it is often difficult for surgeons to distinguish normal from neoplastic tissue or to detect metastatic disease or tumor-infiltrated lymph nodes. In some sites, surgical precision is also required to avoid damage to critical normal tissues. The purpose of this exploratory study is to evaluate the intra-operative and ex vivo fluorescence of BLZ-100 in tumor samples from subjects with breast cancer.
详细描述
Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study. Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study. All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs. Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.
研究者
入排标准
入选标准
- •Male or female subject aged 18 years or older.
- •Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ≥3 months.
- •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. Male subjects with vasectomy do not need to use a second form of contraceptive.
- •Available for all study visits and able to comply with all study requirements.
排除标准
- •Suspected central nervous system (CNS) tumor(s) or sarcoma.
- •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 109/L
- •Platelets \<75 x 109/L
- •Hemoglobin \<10 g/dL (may be determined following transfusion)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN)
- •Total bilirubin \>1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
研究组 & 干预措施
BLZ-100
干预措施: BLZ-100
结局指标
主要结局
Number of participants with adverse events
时间窗: Seven days after study drug administration
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.
次要结局
- Fluorescent signal from excised tumor surgical specimens(Post-tumor excision (approximately 2 hours post BLZ-100 dosing))
- Change of concentration of BLZ-100 in the blood(5, 15, and 30 minutes post BLZ-100 administration)