BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of treatment related toxicities grade ≥3
研究概览
简要总结
This is an open label phase II study to determine the safety and preliminary efficacy of photoimmunotherapy (PIT) for patients with locally advanced and borderline resectable pancreatic cancer.
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
- •Pathologically confirmed pancreatic adenocarcinoma.
- •Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
- •Completed neoadjuvant chemotherapy
- •Neoadjuvant radiation is allowed
- •Planned surgical exploration
- •Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.
- •Patients with a history of biliary obstruction must have adequate biliary drainage.
- •Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:
- •Platelet Count ≥ 75,000/mm
- •Hemoglobin ≥ 8.0 g/dL [NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible] Absolute neutrophil count ≥ 1,000/mm
- •[Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN
- •ECOG performance status 0-1
- •For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with distant metastases.
- •Patients with medical co-morbidities that make them not candidates for surgical exploration
- •Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
- •Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade
- •History of significant (Grade ≥ 3) cetuximab infusion reactions
- •Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
- •No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.
- •Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to PIT illumination.
- •Women who are pregnant or nursing.
- •Patients with concomitant malignancies not expected to cause death within 5 years are eligible.
研究组 & 干预措施
ASP-1929 PIT
Approximately 24 hours prior to surgery patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic. ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700. The following day patients will undergo standard surgical exploration. Patients found to be inoperable will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system. [Patients who are resectable will undergo resection of their pancreatic cancer and will not receive the laser and their tumor will subsequently be evaluated for EGFR receptor saturation.] Part 1: There will be a 10-patient safety run-in Part 2: If Part 1 is acceptable, an additional 20 patients will receive PIT to determine preliminary efficacy in a total of 30 patients
干预措施: ASP-1929 photoimmunotherapy (Combination Product)
结局指标
主要结局
Incidence of treatment related toxicities grade ≥3
时间窗: From start of treatment to 28 days post surgery
Part 1 \| Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery.
Number of Participants Reaching 6 Months Progression Free Survival
时间窗: From start of treatment to 6 months post surgery.
Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival. RECIST version 1.1 will be used to assess for response/progression
次要结局
未报告次要终点