Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccines Alone and in Combination With Toripalimab in Participants With Resected NSCLC

Официальное название

A Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccine Alone and in Combination With Toripalimab in Patients With Resected NSCLC

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of a personalized cancer vaccine alone and in combination with toripalimab in patients with resected NSCLC. The study included dose escalation and dose expansion two parts.

Вмешательства

• Биопрепарат ABO2109 and toripalimab
  Biological : ABO2109 Injection personalized cancer vaccine Biological: 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.]
• DFS based on RECIST Version 1.1 (Dose Expansion) [Срок оценки: 3 years]

Критерии участия

Критерии включения

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 NSCLC and is receiving perioperative and/or adjuvant anti-cancer therapy.
• 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

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
• Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
• 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
• Positive pregnancy test or lactating women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07683832 · ABO2109-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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