NCT07637786尚未招募1 期
An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer
Sichuan University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2026年6月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and preliminary effectiveness of a new combination therapy in patients with advanced pancreatic cancer.
The main questions it aims to answer are:
- Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?
- Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?
Participants will be asked to:
- Receive doses of the peptide nanovaccine (ONVAX-01).
- Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.
- Undergo regular physical exams, blood tests, and imaging scans (such as CT or MRI) to monitor their health and the tumor's response to the treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age between 18 and 75 years (inclusive).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histologically confirmed, KRAS-mutated, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
- •Documented disease progression after at least one prior line of systemic therapy.
- •Estimated life expectancy of ≥ 12 weeks.
- •At least one measurable objective tumor lesion according to RECIST v1.
- •The maximum diameter must be ≥ 1 cm by spiral CT, or ≥ 2 cm by standard CT or MRI; imaging must be performed within 28 days prior to enrollment.
- •Adequate bone marrow and organ function, defined as follows (without the use of hematopoietic growth factors or blood transfusions within 7 days prior to testing):
- •Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L, and hemoglobin ≥ 90 g/L.
- •Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
- •Renal: Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula).
- •Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
- •Cardiac: Normal electrocardiogram (ECG) or abnormal ECG deemed clinically insignificant by the investigator.
- •Urinalysis: Urine protein < 2+; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be < 1.0 g.
- •Participants of childbearing potential must agree to use highly effective contraceptive measures from study entry throughout the study period.
- •Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have received at least 14 days of continuous antiviral therapy prior to the first study dose. HBV DNA titer must be ≤ 500 IU/mL (or 2500 copies/mL) and HCV RNA must be below the lower limit of detection. Participants must be willing to continue effective antiviral therapy during the study.
排除标准
- •• Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine.
- •History of other malignancies, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer (Ta and TIS), or other malignancies curatively treated at least 5 years prior to enrollment.
- •Uncontrolled concomitant diseases, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.
- •Prior treatment with any antibody or drug targeting T-cell co-regulatory proteins (immune checkpoints), such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 antibodies.
- •Human Immunodeficiency Virus (HIV) infection, or active uncontrolled HBV (HBV DNA ≥ 500 IU/mL) or HCV infection.
- •Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or any other medical conditions deemed unsuitable for enrollment by the investigator.
- •Active autoimmune disease, primary or secondary immunodeficiency, or current treatment with immunosuppressive medications.
- •Pregnant or lactating women.
- •Receipt of any prophylactic vaccines for infectious diseases within 4 weeks prior to the first dose, or planned vaccination during the study up to 8 weeks after the last dose.
- •History of severe allergic reactions to prior prophylactic vaccines.
- •Known allergy or hypersensitivity to the investigational drugs or any of their excipients.
- •History of substance abuse, or any clinical, psychological, or social factors that would preclude the administration of immunotherapy.
- •Significant weight loss (≥ 10% of body weight) within 6 weeks prior to enrollment.
- •Any other condition or uncertainty that, in the investigator's judgment, could compromise patient safety or compliance with the study protocol.
研究组 & 干预措施
ONVAX-01 + Anti-PD-1 Antibody + Chemotherapy
Experimental
Participants with pancreatic ductal adenocarcinoma will receive a combination therapy of peptide nanovaccine (ONVAX-01), anti-PD-1, and standard chemotherapy.
Treatment Schema:
Induction Phase: Participants receive ONVAX-01 and anti-PD-1 in combination with investigator-selected chemotherapy (either AG regimen or NALIRIFOX regimen) for 6-12 cycles.
Maintenance Phase: Participants achieving clinical benefit (CR, PR, or SD) will continue treatment with ONVAX-01 and anti-PD-1.
Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.
干预措施: ONVAX-01 plus Anti-PD-1 and Chemotherapy (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From the first dose of study treatment up to 36 weeks after the last dose.
次要结局
- Objective Response Rate (ORR)(Up to disease progression or unacceptable toxicity (Up to approximately 24 months).)
- Disease Control Rate (DCR)(Up to disease progression or unacceptable toxicity (Up to approximately 24 months).)
- Progression-Free Survival (PFS)(Up to 24 months.)
- Overall Survival (OS)(Up to 36 months.)
研究者
Zhen-Yu Ding
Professor
Sichuan University
研究点 (1)
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