NCT07560943招募中1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of an Artificial Intelligence-Designed Tumor mRNA Vaccine in Patients With Advanced or Metastatic Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of Participants with DLT
研究概览
简要总结
This is a phase I, open-label, single-arm, single-center, dose-escalation study to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of PAN-NeoVax, an artificial intelligence (AI)-designed pan-cancer neoantigen mRNA vaccine delivered via lipid nanoparticles (LNP), administered by intratumoral injection in patients with advanced or metastatic solid tumors who have failed second-line therapy. The study employs a classical "3+3" dose-escalation design with three dose levels (25 μg, 50 μg, and 100 μg mRNA). Each subject will receive 5 doses of basic immunization (first 4 doses at weekly intervals, fifth dose at 1 month after the fourth dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥18 and ≤70 years
- •Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that have failed second-line therapy with no standard treatment options available (priority enrollment of advanced head and neck squamous cell carcinoma and malignant melanoma patients)
- •ECOG Performance Status score: 0-1
- •Estimated life expectancy ≥3 months
- •At least 28 days since prior chemotherapy, radiotherapy, or surgery
- •At least 6 weeks since prior use of nitrosoureas or mitomycin C
- •Adequate organ function within 14 days prior to enrollment:
- •Hemoglobin ≥90 g/L (no blood transfusion within 14 days)
- •Absolute neutrophil count >1.5×10⁹/L
- •Platelet count ≥80×10⁹/L
- •Total bilirubin ≤1.5×ULN
- •ALT or AST ≤2.5×ULN (≤5×ULN if liver metastases present)
- •Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
- •Left ventricular ejection fraction (LVEF) ≥50%
- •Signed written informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements
排除标准
- •Participation in another clinical drug trial within 4 weeks
- •Tumor located adjacent to major blood vessels or trachea
- •Poorly controlled cardiac conditions: NYHA class >2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- •Pregnant or breastfeeding women
- •Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE v5.0); HIV infection, active HBV or HCV infection
- •History of psychotropic substance abuse that cannot be discontinued, or mental disorders
- •Active autoimmune disease or history of autoimmune disease (exceptions: vitiligo; childhood asthma in complete remission requiring no adult intervention; asthma requiring bronchodilator intervention is excluded)
- •Currently receiving immunosuppressive therapy
- •History of drug abuse or known medical, psychological, or social conditions (e.g., alcoholism, drug addiction)
- •Known allergy, hypersensitivity, or intolerance to PAN-NeoVax or any excipient; history of severe allergic reactions to any drug, food, or vaccine (including anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, Arthus reaction)
- •Female subjects with pregnancy plans or male subjects whose partners have pregnancy plans from screening through 12 months after the last dose
- •Any serious concomitant disease that, in the investigator's judgment, would jeopardize patient safety or ability to complete the study
研究组 & 干预措施
PAN-NeoVax Dose Level 3 (100 μg)
Experimental
干预措施: PAN-NeoVax (100 μg) (Biological)
PAN-NeoVax Dose Level 2 (50 μg)
Experimental
干预措施: PAN-NeoVax (50 μg) (Biological)
PAN-NeoVax Dose Level 1 (25 μg)
Experimental
干预措施: PAN-NeoVax (25 μg) (Biological)
结局指标
主要结局
Number of Participants with DLT
时间窗: From the first dose to 3 weeks post-dose.
次要结局
- Disease Control Rate(From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.)
- Time to First Response(From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.)
- Duration of Response(From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.)
- Progression - Free Survival(PFS)(From the time when the patients were enrolled in the study until three months after the last dose was injected. The time window was typically 6 months.)
- Overall Survival(OS)(From the time when the patients were enrolled in the study until six months after the last dose was injected. The time window was typically 8 months.)
- Objective Response Rate(From the time when the patients were enrolled in the study until one month after the last dose was injected.The time window was typically 2 months.)
研究者
Xingchen Peng
Professor
West China Hospital
研究点 (2)
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