NCT05589597终止1 期
A Global Multicenter Phase 1/2 Trial of EO4010, a Novel Microbial Derived Peptide Therapeutic Vaccine, in Combination With Nivolumab and/or Bevacizumab, for Treatment of Patients With Previously Treated Metastatic Colorectal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Enterome
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Safety and tolerability of EO4010 in combination with nivolumab and/or bevacizumab
研究概览
简要总结
Open-label multicenter study
详细描述
This is an open-label, multicenter, FIH, phase 1/2 trial to assess safety, tolerability, immunogenicity, and preliminary efficacy of the microbial-derived therapeutic vaccine EO4010 in combination with nivolumab and/or bevacizumab for treatment of patients with unresectable, previously treated, metastatic colorectal cancer
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
- •Provided written informed consent
- •Histological confirmation of advanced non-resectable colorectal adenocarcinoma
- •Patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for
- •Progression during or within 3 months following the latest administration of standard therapies
- •Age ≥ 18 years old
- •Human leukocyte antigen (HLA)-A2 positive
- •ECOG performance status 0 or 1
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria (RECIST)
- •Patients with a life expectancy of at least 3 months
- •Female patients of childbearing potential must have a negative serum pregnancy test
- •Patients following recommendations for contraception
- •Patients willing and able to comply with the study procedures
排除标准
- •Patients treated with dexamethasone > 2 mg/day or equivalent within 14 days before randomization, unless required to treat an adverse event
- •Patients treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days
- •Patients with persistent Grade ≥ 2 toxicities (according to NCI-CTCAE v5.0). Toxicities must be resolved for at least 2 weeks to Grade 1 or less
- •Patients who have received any prior treatment with compounds targeting PD1, PDL1, CTLA-4, or similar compounds
- •Patients who have previously received trifluridine/tipiracil (TAS-102) or regorafenib
- •Patients with prior exposure to EO2401, EO2040, or EO4010, i.e. therapeutic vaccine compounds including all or some components of EO4010
- •Patients with the following abnormal laboratory values:
- •Lymphocyte count decreased, grade 2 (lymphocytes <800 - 500/mm3; <0.8 - 0.5 x 109/L), or worse grade
- •Hemoglobin < 10 g/dL (6.2 mmol/L); transfusion is acceptable to reach the value
- •Absolute neutrophil count decrease (<1.5 x109/L)
- •Platelet count decrease (< 75 ×109/L)
- •Total bilirubin > 1.5 ×upper limit of normal
- •Alanine aminotransferase (ALT) > 3 ×ULN; if disease metastatic to the liver > 5 xULN
- •Aspartate aminotransferase (AST) > 3 ×ULN; if disease metastatic to the liver > 5 xULN
- •Serum creatinine increase (> 1.5 ×ULN)
- •Abnormal thyroid function per local laboratory levels
- •Other malignancy or prior malignancy with a disease-free interval of less than 3 years prior to ICF signing; except those treated with surgical intervention and an expected low likelihood of recurrence
- •Patients with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition
- •Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g., Guillain-Barré syndrome)
- •Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation
- •Patients with a history or known presence of tuberculosis
- •Pregnant and breastfeeding patients
- •Patients with a history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV)
- •Uncontrolled central nervous system (CNS) metastasis
- •Patients who have received live or attenuated vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug
- •Patients with a history of hypersensitivity to any excipient, or active substance, present in the pharmaceutical forms of applicable study treatments
- •Patients under treatment with immunostimulatory or immunosuppressive medications
- •Patients who have received treatment with any other investigational agent, or participation in another clinical trial
研究组 & 干预措施
Cohort 1
Experimental
E04010 Monotherapy
干预措施: EO4010 (Drug)
Cohort 2
Experimental
E04010 in combination with nivolumab
干预措施: EO4010 (Drug)
Cohort 3
Experimental
E04010 in combination with nivolumab and/or bevacizumab
干预措施: EO4010 (Drug)
结局指标
主要结局
Safety and tolerability of EO4010 in combination with nivolumab and/or bevacizumab
时间窗: 12months
Incidences of AEs, treatment-emergent AEs (TEAEs), Serious Adverse Events (SAEs), deaths, and laboratory abnormalities using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
次要结局
- Overall response rate(12 months)
- Disease control rate(12 months)
- Percentage of patients with shown immunogenicity(12 months)
- Time to response(12 months)
- Duration of response(12 months)
- Progression free survival(4months)
- Overall survival to the date of death due to any cause. Patients alive will be censored at the date of the last documented follow-up(12 months)
研究者
研究点 (6)
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