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Virus Therapy
EO4010 for Colorectal Cancer (AUDREY Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Enterome
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12months
Awards & highlights
AUDREY Trial Summary
This trial tests a new drug on participants at multiple locations with no placebo or blinds.
Who is the study for?
This trial is for adults over 18 with advanced, non-resectable colorectal adenocarcinoma that's HLA-A2 positive. They must have had prior treatment or be unsuitable for standard therapies, have a life expectancy of at least 3 months, and agree to contraception. Exclusions include recent high-dose steroids or chemotherapy, unresolved toxicities, certain abnormal lab values (like low blood counts), active infections including TB/HIV/HBV/HCV, pregnancy/breastfeeding, history of severe allergies to study drug components or autoimmune disorders.Check my eligibility
What is being tested?
EO4010 is being tested in this open-label multicenter study on patients with metastatic colorectal cancer who've already undergone treatment. The focus is on the safety and effectiveness of EO4010 as a potential new therapy option.See study design
What are the potential side effects?
While specific side effects for EO4010 are not listed here, common side effects from similar cancer treatments may include fatigue, nausea, diarrhea, lowered immunity leading to increased infection risk; allergic reactions; and potentially organ-specific inflammation.
AUDREY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of EO4010 in combination with nivolumab
Secondary outcome measures
Disease control rate
Duration of response
Overall response rate
+4 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
AUDREY Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
E04010 in combination with nivolumab
Group II: Cohort 2Experimental Treatment1 Intervention
E04010 in combination with nivolumab
Group III: Cohort 1Experimental Treatment1 Intervention
E04010 Monotherapy
Find a Location
Who is running the clinical trial?
EnteromeLead Sponsor
8 Previous Clinical Trials
511 Total Patients Enrolled
Jan FagerbergStudy DirectorEnterome
1 Previous Clinical Trials
70 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the participant recruitment for this trial?
"Affirmative. The clinicaltrials.gov website attests to the fact that this medical trial, first published on June 1st 2023, is currently enrolling participants. A total of 42 patients need to be recruited from 5 different sites."
Answered by AI
Are there still vacancies for participants in this experiment?
"Affirmative. Recent records on clinicaltrials.gov show that recruitment for this medical experiment is occurring, having been posted June 1st of 2023 and last modified October 19th 23rd. 42 participants are needed across 5 different sites."
Answered by AI
Are there any US-based facilities engaged in the current trial protocol?
"This clinical trial is being hosted at Hôpital Jean Minjoz in Besançon, ICM Val d'Aurelle in Montpellier and Hospital Universitari Vall d'Hebron in Barcelona. Additionally, two other medical centres are accommodating the study."
Answered by AI
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