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Идёт набор NCT07680582

An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors

Ранняя фаза I С лечением Solid Tumor

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: ABO2109 Injection, Toripalimab.
Кому может быть актуально
Состояния в реестре: Solid Tumor. 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
Китай
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

An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors

Обзор

The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine. In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.

Вмешательства

  • Препарат ABO2109 Injection
    personalized cancer vaccine
  • Препарат Toripalimab
    Anti-PD-1 monoclonal antibody

Первичные конечные точки

  • Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration) [Срок оценки: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort]
  • Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration) [Срок оценки: From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first]
  • Changes in ECOG performance status score (Dose Exploration) [Срок оценки: From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first.]
  • Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion) [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • ≥18 years of age at time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Life expectancy of ≥6 months
  • Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
  • No evidence of disease progression per investigator within 28 days before the first dose of study intervention
  • Sufficient organ function
  • Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.

Критерии исключения

  • For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
  • Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer
  • Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
  • Presence of active infections
  • History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
  • Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.

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

Китай · 1 центр
  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07680582 · ABO2109-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗