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Набор скоро начнётся NCT07698613

EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer

Фаза I / Фаза II С лечением Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection Pancreatic Cancer Borderline Pancreatic Cancer Resectable

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ASP-1929 photoimmunotherapy.
Кому может быть актуально
Состояния в реестре: Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection, Pancreatic Cancer Borderline, Pancreatic Cancer Resectable. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer

Обзор

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.

Вмешательства

  • Комбинированный продукт ASP-1929 photoimmunotherapy
    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 (IRDye 700DX). The following day patients will undergo standard surgical exploration. Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation

Первичные конечные точки

  • Incidence of treatment related toxicities grade ≥3 [Срок оценки: From start of treatment to 28 days post surgery]
  • Number of Participants Reaching 6 Months Progression Free Survival [Срок оценки: From start of treatment to 6 months post surgery.]

Критерии участия

Критерии включения

  • 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/mm3. 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/mm3. \[Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1\] 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

  • Age ≥ 18
  • 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.

Критерии исключения

  • 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 2.
  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Rhode Island and the Miriam Hospitals (Brown University Health) — Providence

Идентификаторы

NCT: NCT07698613 · BrUOG 438 · 1929-IIR-0016

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗