A Study of EP0031 in Patients With Advanced RET-altered Malignancies
NCT ID: NCT05443126
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
265 participants
INTERVENTIONAL
2022-09-30
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RET fusion-positive NSCLC (prior 1st gen SRI)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
RET mutation-positive MTC (prior 1st gen SRI)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Other RET-altered solid tumours (prior 1st gen SRI)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
RET fusion-positive NSCLC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
RET mutation-positive MTC (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Other RET-altered solid tumours (no prior SRI therapy)
EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Interventions
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EP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Eligibility Criteria
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Inclusion Criteria
1. Must be ≥18 years of age, with documented RET-altered cancers
2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
5. Additional cohort specific criteria apply
Exclusion Criteria
1. Any known major driver gene alterations other than RET.
2. Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
3. Active infection requiring systemic antibiotic, antifungal, or antiviral medication
4. Severe or uncontrolled medical condition or psychiatric condition
5. Chronic glomerulonephritis or renal transplant
6. Patients with active hepatitis B infection or active hepatitis C
7. Patients with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 months
8. Receipt of any strong inhibitor or inducer of CYP3A4
9. Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
10. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade II-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months
11. Uncontrolled hypertension
12. Corneal ulceration at screening
18 Years
ALL
No
Sponsors
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Ellipses Pharma
INDUSTRY
Responsible Party
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Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Florida Cancer Specialist
Fort Myers, Florida, United States
RUSH University Medical Center
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYU Langone Health
New York, New York, United States
Providence Portland Medical Centre
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sarah Cannon
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Washington University
Seattle, Washington, United States
Seattle Cancer Care / Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Assistance publique - Hôpitaux de Marseille
Marseille, Bouches-du-Rhône, France
Center Bergonié
Bordeaux, Gironde, France
Institut Gustave-Roussy
Villejuif, Paris, France
Centre François Baclesse
Caen, , France
Centre Léon Bérard
Lyon, , France
Charité Comprehensive Cancer Center
Berlin, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Hospital Universitario de A Coruña
A Coruña, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
University Hospital October 12
Madrid, , Spain
Hospital Madrid Sanchinarro
Madrid, , Spain
Hospital Virgen de la Victoria de Malaga
Málaga, , Spain
Tawam Hospital
Al Ain City, Abu Dhabi Emirate, United Arab Emirates
Sheik Shakhbout Medical City (SSMC)
Abu Dhabi, , United Arab Emirates
Cleveland Clinic Abu Dhabi (CCAD)
Abu Dhabi, , United Arab Emirates
University College London Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Nurse Navigator Hotline
Role: primary
Pascale Tomasini, Dr
Role: primary
Role: backup
Antoine Italiano, Dr
Role: primary
Role: backup
Role: primary
Role: primary
Selvaraj Giridharan, Dr
Role: primary
Hassan Shahryar Sheik, Dr
Role: primary
Other Identifiers
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EP0031-101
Identifier Type: -
Identifier Source: org_study_id
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