A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Part II: Overall Response Rate (ORR) per RECIST version 1.1.
研究概览
简要总结
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
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 —（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.
- •Participants with histologically and/ or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment.
- •Harboring at least one of the targeted KRAS mutants.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0~
- •Life expectancy of ≥12 weeks.
- •Sufficient organ function.
排除标准
- •Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- •Received KRAS cancer vaccine before.
- •Immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. Physiological doses of systemic steroids or topical medications are allowed. Topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; Or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs.
- •History of severe allergies or known allergies to any active or inactive component of the study drug(s).
- •Uncontrolled systemic infection; active tuberculosis.
- •Severe cardiovascular diseases.
- •Has known symptomatic, untreated central nervous system metastases, or CNS metastases requiring continued treatment. Participants with asymptomatic brain metastases and who do not require treatment are eligible for enrolment.
- •Have active autoimmune and inflammatory diseases.
- •Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids.
- •Have other serious medical conditions
- •A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
研究组 & 干预措施
ABO2102
Prat I: Monotherapy
干预措施: ABO2102 (Drug)
ABO2102 and Toripalimab
Part I&II: ABO2102 in combination with Toripalimab
干预措施: ABO2102 (Drug)
ABO2102 and Toripalimab
Part I&II: ABO2102 in combination with Toripalimab
干预措施: Toripalimab (Drug)
结局指标
主要结局
Part II: Overall Response Rate (ORR) per RECIST version 1.1.
时间窗: from the first dose of study treatment to up to 2 years.
Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment.
时间窗: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of serious TEAEs (TESAE)s.
时间窗: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab.
时间窗: 21 days after the first dose of study treatment
Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s.
时间窗: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
次要结局
未报告次要终点