A Novel Therapeutic Vaccine (EO2401) in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

Study Purpose

This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Main

Inclusion Criteria:

1. For inclusion in Cohort 1 patients should have adrenocortical carcinoma(ACC), or malignant pheochromocytoma/paraganglioma (MPP), as defined below for Cohorts 2A and 3A. 2. For inclusion in Cohorts 2A and 2B patients should have histologically confirmed (at primary diagnosis) unresectable locally advanced or metastatic adrenocortical carcinoma. 3. For inclusion in Cohorts 3A and 3B patients should have histologically confirmed (at primary diagnosis) unresectable malignant (defined as metastatic disease, i.e. presence of chromaffin tissue in non-chromaffin organs) pheochromocytoma/paraganglioma, and RECIST defined progression should have been documented during a maximum of an 18-months period. 4. Patients with an age ≥ 18 years old. 5. Patients who are human leukocyte antigen (HLA)-A2 positive. 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 7. Patients with a life expectancy > 4 months as judged by their treating physician. 8. Patients with at least one measurable lesion according to RECIST 1.1. 9. Males or non-pregnant, non-lactating, females. 10. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. 11. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures. Main

Exclusion Criteria:

1. Patients treated with dexamethasone > 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2401 administration, unless required to treat an adverse event. 2. Patients with prior treatment with immune check-point inhibitors. 3. Patients with prior exposure to EO2401. 4. Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2401 administration. 5. Patients with ACC with more than three organs involved by disease, combined with unresectable primary tumor. 6. Patients with ACC and uncontrolled hormonal secretion (according to the judgement of the treating physician). 7. Patients with MPP and uncontrolled blood pressure (according to the judgement of the treating physician). 8. Patients with abnormal laboratory values. 9. Patients with persistent Grade 3 or 4 toxicities. 10. Uncontrolled central nervous system (CNS) metastasis. 11. Other malignancy or prior malignancy with a disease-free interval of less than 3 years. 12. Patients with clinically significant disease. 13. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome). 14. Patients with history of solid organ transplantation or hematopoietic stem cell transplantation. 15. Patients with history or known presence of tuberculosis. 16. Pregnant and breastfeeding patients. 17. Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection. 18. 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. 19. Patients with a history of hypersensitivity to any excipient present in the pharmaceutical forms of the study treatments. 20. Patients treated with herbal remedies with immunostimulating properties or known to potentially interfere with major organ function. 21. Patients with known ongoing drug and alcohol abuse. 22. Patients with known or underlying medical or psychiatric condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or AEs. 23. Patients deprived of their liberty, under protective custody, or guardship.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04187404
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Enterome
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jan Fagerberg
Principal Investigator Affiliation Enterome
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Denmark, France, Germany, Italy, Netherlands, Spain, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adrenocortical Carcinoma, Pheochromocytoma, Paraganglioma
Additional Details

EO2401 is an innovative cancer peptide therapeutic vaccine based on the homologies between Tumor Associated Antigens and microbiome-derived peptides that will be administered in combination with nivolumab to generate preliminary safety and efficacy data in patients with Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.

Arms & Interventions

Arms

Experimental: 5-cohort study design

Cohort 1:3-by-3 design of EO2401 in combination with nivolumab at standard dose. Three to 12 evaluable patients with adrenal carcinoma or progressive malignant pheochromocytoma/paraganglioma will be included depending on the safety profile of the administered treatments. Cohorts 2A (previously treated patients) and 2B (previously untreated patients): evaluation of EO2401 at the recommended dose found in Cohort 1 in combination with nivolumab in 30 evaluable patients (15 each for Cohorts 2A and 2B) with adrenal carcinoma. Cohorts 3A (previously treated patients) and 3B (previously untreated patients) : evaluation of EO2401 at the recommended dose found in Cohort 1 in combination with nivolumab in 30 evaluable patients (15 each for Cohorts 3A and 3B) with progressive malignant pheochromocytoma/paraganglioma.

Interventions

Biological: - EO2401

Multiple dose of EO2041 in combination with nivolumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Vivek Subbiah, MD

VSubbiah@mdanderson.org

+33 1 76 21 58 16

International Sites

Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

Rigshospitalet

Copenhagen, , 2100

Site Contact

Kirsten Gedske Daugaard, MD

kirsten.gedske.daugaard@regionh.dk

+33 1 76 21 58 16

Centre Léon Bérard, Lyon, France

Status

Recruiting

Address

Centre Léon Bérard

Lyon, , 69008

Site Contact

Christelle de la Fouchardière, MD

christelle.delafouchardiere@lyon.unicancer.fr

+33 1 76 21 58 16

Institut Gustave Roussy, Villejuif, France

Status

Recruiting

Address

Institut Gustave Roussy

Villejuif, , 94800

Lmu Klinikum, München, Germany

Status

Recruiting

Address

Lmu Klinikum

München, ,

Site Contact

Matthias Kroiß, MD

Matthias.Kroiss@med.uni-muenchen.de

+33 1 76 21 58 16

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

Azienda Ospedaliera Spedali Civili, Brescia, Italy

Status

Recruiting

Address

Azienda Ospedaliera Spedali Civili

Brescia, , 25121

Site Contact

Salvatore Grisanti, MD

mmas@enterome.com

+33 1 76 21 58 16

Máxima Medisch Centrum, Eindhoven, Netherlands

Status

Recruiting

Address

Máxima Medisch Centrum

Eindhoven, , 5631

Site Contact

Catharina Willemien Menke, MD

Mc.menke@amsterdamumc.nl

+33 1 76 21 58 16

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron

Barcelona, , 08035

Site Contact

Jaume Capdevilla, MD

jcapdevila@vhio.net

+33 1 76 21 58 16

Karolinska University Hospital, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital

Stockholm, , 17176

Site Contact

Dan Granberg, MD

dan.granberg1954@icloud.com

+33 1 76 21 58 16

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