A Microdose Evaluation Study of ABY-029 in Primary Sarcoma
Кључне речи
Апстрактан
Опис
The investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma in this open label, single center, clinical trial of ABY-029. The study will enroll patients with an EGFR pathology score ≥ 1.
Initial diagnostic biopsy specimens will be analyzed for EGFR positivity by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery. Following tumor excision, the tumor will be transported to the Pathologist and will be inked and sectioned. Following sectioning the tumor will be imaged using a near-infrared scanner and fiber-probe based system. Quantitative measurements of fluorophore concentration will be measured for tumors with EGFR pathology score ≥ 1 and compared to those with EGFR pathology score < 1. Quantitative mapping of fluorophore concentration will be correlated with local EGFR concentration and blood vessel density. Upon specimen analysis, fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. Average EGFR concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in ABY-029 concentration based upon near-infrared scan results.
The protocol is not a safety study since no physiological effects are expected at microdose levels of ABY-029. No diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned tumor resection during the surgical procedure.
Датуми
| Последња верификација: | 01/31/2020 |
| Фирст Субмиттед: | 05/11/2017 |
| Предвиђена пријава послата: | 05/14/2017 |
| Прво објављено: | 05/15/2017 |
| Послато последње ажурирање: | 05/12/2020 |
| Последње ажурирање објављено: | 05/13/2020 |
| Стварни датум почетка студије: | 08/29/2017 |
| Процењени датум примарног завршетка: | 12/30/2020 |
| Предвиђени датум завршетка студије: | 12/30/2020 |
Стање или болест
Интервенција / лечење
Drug: ABY-029
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: ABY-029 ABY-029 will be administered prior to surgery and tissue will be examined ex vivo to determine binding with EGFR positive tumor tissue. | Drug: ABY-029 A minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma will be enrolled. Initial diagnostic biopsy specimens will be analyzed for EGFR positivity (an EGFR pathology score ≥ 1) by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery. |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: 1. Preoperative histological diagnosis of primary sarcoma. 2. Tumor judged to be suitable for open surgical resection based on preoperative imaging studies. 3. Valid informed consent by subject. 4. Age ≥ 18 years old. Exclusion Criteria: 1. Pregnant women or women who are breast feeding. 2. Patients on any experimental anti-EGFR targeted therapies, either investigational or FDA approved. |
Исход
Примарне мере исхода
1. Signal detection [Day of surgery, up to 1 week after surgery]
Секундарне мере исхода
1. Correlation of spatial patterns of EGFR expression [within 1 week of surgery]
2. molecular uptake and ABY-029 concentration [within 1 week of surgery]
