2023-509509-62-00已完成2 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 (the "AUDREY" study).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Enterome
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- The primary endpoint includes safety and tolerability of EO4010 in combination with nivolumab, and/or with bevacizumab by a descriptive medical assessment of the combined profile of incidences of adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), deaths, reasons for treatment discontinuation/delays, and laboratory abnormalities using the NCI-CTCAE v5.0 grading system.
研究概览
简要总结
The primary objective of this trial is to evaluate safety and tolerability of EO4010 in combination with nivolumab and/or with bevacizumab in patients with unresectable, previously treated locally advanced or mCRC.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post-study treatment follow-up visits
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •HLA-A2 positive patients with advanced non-resectable colorectal adenocarcinoma which is mismatch repair proficient and microsatellite stable, who have been previously treated with, or are not considered candidates therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents
- •Progression during or within 3 months following the latest administration of standard therapies (outlined above)
- •at an age ≥ 18 years
- •ECOG performance status 0 to 1.
排除标准
- •patients treated with dexamethasone > 2 mg/day or equivalent (i.e., 13 mg/day of prednisone) within 14 days before first administration of EO4010
- •who have received any prior treatment with compounds targeting PD1, PD-L1, CTLA-4, or similar compounds, trifluridine/tipiracil (TAS-102) or regorafenib
- •treated with radiotherapy within 12 weeks, and cytotoxic chemotherapy therapy within 28 days (or 5 half-lives of the compound(s) administered if longer) before study treatment start
- •With persistent Grade ≥ 2 toxicities (according to NCI-CTCAE v5.0). except alopecia, neuropathy, and other persisting toxicities not constituting a safety risk based on Investigator’s judgment
- •With uncontrolled central nervous system (CNS) metastasis
- •with the significant abnormal laboratory values hematology, liver and renal function
- •with clinically significant active infection, cardiac disease, significant medical or psychiatric disease/condition that, in the opinion of the Investigator, would interfere with the interpretation of patient safety or study results or that would prohibit the understanding or rendering of informed consent
- •Patients with a history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation
- •history or presence of human immunodeficiency virus (HIV) and/or active hepatitis B virus (HBV)/hepatitis C virus (HCV).
结局指标
主要结局
The primary endpoint includes safety and tolerability of EO4010 in combination with nivolumab, and/or with bevacizumab by a descriptive medical assessment of the combined profile of incidences of adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), deaths, reasons for treatment discontinuation/delays, and laboratory abnormalities using the NCI-CTCAE v5.0 grading system.
The primary endpoint includes safety and tolerability of EO4010 in combination with nivolumab, and/or with bevacizumab by a descriptive medical assessment of the combined profile of incidences of adverse events (AEs), treatment-emergent AEs (TEAEs), serious AEs (SAEs), deaths, reasons for treatment discontinuation/delays, and laboratory abnormalities using the NCI-CTCAE v5.0 grading system.
次要结局
- TTR
- DCR
- percentage of patients with shown immunogenicity (expansion of specific T cells comparing samples taken at baseline versus on treatment in an individual patient determining if the patient has a positive response to the immunization, or not) in relation to each peptide composing EO4010 by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot), and by intracellular cytokines staining, or multimers staining assays.
- Cross-reactivities with the human TAAs.
- ORR
- DOR and
- PFS as described by RECIST 1.1 and iRECIST criteria.
- OS
研究者
Enterome SA Medical
Scientific
Enterome
研究点 (5)
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