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). - EOCRC2-22

Enterome0 个研究点目标入组 42 人开始时间: 2024年6月14日最近更新: 2024年8月21日

适应症

试验速览

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•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.

•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).

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