An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in ECOG performance status score (Dose Exploration)
研究概览
简要总结
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.
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
- •≥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.
排除标准
- •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.
研究组 & 干预措施
Dose Exploration Part
For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner.
干预措施: ABO2109 Injection (Drug)
Dose Exploration Part
For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Changes in ECOG performance status score (Dose Exploration)
时间窗: 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)
时间窗: 5 years
Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)
时间窗: 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
Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)
时间窗: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
次要结局
未报告次要终点