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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

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

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.

研究概览

地位

尚未招聘

研究类型

介入性

注册 (估计的)

50

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Key inclusion criteria:

  • ≥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.

Exclusion Criteria:

Key Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:ABO2109 combined with toripalimab
Participants will receive ABO2109 at specified dose defined in the study protocol via an intramuscular (IM) injection every three weeks. The first treatment cycle consists of ABO2109 monotherapy, and combination therapy with toripalimab is initiated from the second treatment cycle onwards.
Biological : ABO2109 Injection personalized cancer vaccine Biological: Toripalimab Anti-PD-1 monoclonal antibody

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy(Dose Exploration)
大体时间:From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
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)
大体时间: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.
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)
大体时间: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.
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)
大体时间:3 years
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月28日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2031年4月17日

研究注册日期

首次提交

2026年4月17日

首先提交符合 QC 标准的

2026年7月1日

首次发布 (实际的)

2026年7月6日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ABO2109-003

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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