Clinical Trials

ROSALIE – EO2401 in Glioblastoma

ROSALIE (EOGBM1-18) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo®) for the treatment of patients with first progression/recurrence of glioblastoma (GB).

The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in approximately 52 patients enrolled at ten clinical sites in Europe and the US.

ClinicalTrials.gov Identifier: NCT04116658


SPENCER – EO2401 in Adrenal tumors

SPENCER (EOADR1-19) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma.

The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in first- and second-line treatment in approximately 60 patients enrolled at ten clinical sites in Europe and the US.

ClinicalTrials.gov Identifier: NCT04187404


SIDNEY – EO2463 in Indolent non-Hodgkin Lymphoma

SIDNEY (EONHL1-20) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2463 as monotherapy and in combination with lenalidomide and/or rituximab for the treatment of patients with indolent non-Hodgkin lymphoma (iNHL).

The study aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy in approximately 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

The study has received regulatory approvals in Italy, Spain, France and the USA with the clearance of the Investigational New Drug (IND). The first patient is expected to be dosed in Q2 2021.

ClinicalTrials.gov Identifier: NCT04669171


SYMMETRY – Sibofimloc/TAK-018 in Crohn’s Disease

SYMMETRY is a randomized, double-blind, placebo-controlled, multicenter, Phase 2a study to evaluate the safety, tolerability and early proof of concept of Sibofimloc/TAK-018 for the prevention of post-operative recurrence of Crohn’s Disease. Patients will be randomized (1:1:1) to receive either low dose or high dose Sibofimloc/TAK-018 or placebo.

The primary endpoint of the study is the percentage of participants with endoscopic recurrence of Crohn’s Disease. The study aims to enroll up to 96 post-operative participants with Crohn’s disease at about 40 sites in Europe and the US.

The study is being run in collaboration with Takeda Pharmaceuticals. The first patient was dosed in September 2020 and results are expected in 2023.

A Phase 1b study of Sibofimloc/TAK-018 found the product to be well tolerated in patients with Crohn’s Disease (Ref PR).

ClinicalTrials.gov Identifier: NCT03943446

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