A Study of EP0031 in Patients With Advanced RET-altered Malignancies

NCT05443126 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EP0031-101
• Study Type: interventional
• Target: 265
• Locations: 7 countries
• Sites: 40

Brief Summary

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)

Conditions

Advanced Solid Tumor; NSCLC

Keywords

selective RET-inhibitor; NSCLC; RET

Outcome Measures

Primary Outcomes (2)

• Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment

  First 28 days of treatment

• Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1

  12 months

Secondary Outcomes (3)

• Area under the plasma concentration versus time curve (AUC)

  First 48 hours after drug administered

• Maximum Plasma Concentration (Cmax)

  First 24 hours after drug administered

• Time taken for drug concentration to fall from half its original value (Half-life)

  First 72 hours after drug administered

Study Arms (6)

RET fusion-positive NSCLC (prior 1st gen SRI)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

RET mutation-positive MTC (prior 1st gen SRI)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

Other RET-altered solid tumours (prior 1st gen SRI)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

RET fusion-positive NSCLC (no prior SRI therapy)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

RET mutation-positive MTC (no prior SRI therapy)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

Other RET-altered solid tumours (no prior SRI therapy)

EXPERIMENTAL

EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Drug: EP0031

Interventions

EP0031 DRUG

EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Other RET-altered solid tumours (no prior SRI therapy); Other RET-altered solid tumours (prior 1st gen SRI); RET fusion-positive NSCLC (no prior SRI therapy); RET fusion-positive NSCLC (prior 1st gen SRI); RET mutation-positive MTC (no prior SRI therapy); RET mutation-positive MTC (prior 1st gen SRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Applicable to all patients:
• Must be ≥18 years of age, with documented RET-altered cancers
• Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
• ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
• Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
• Additional cohort specific criteria apply

You may not qualify if:

• Patients with any of the following will not be included in the study:
• Any known major driver gene alterations other than RET.
• Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.
• Active infection requiring systemic antibiotic, antifungal, or antiviral medication
• Severe or uncontrolled medical condition or psychiatric condition
• Chronic glomerulonephritis or renal transplant
• Patients with active hepatitis B infection or active hepatitis C
• 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
• Receipt of any strong inhibitor or inducer of CYP3A4
• Impaired hepatic or renal function, inadequate bone marrow reserve or organ function
• 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
• Uncontrolled hypertension
• Corneal ulceration at screening

Sponsors & Collaborators

• Ellipses Pharma: lead

Study Sites (40)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20057, United States

RECRUITING

Florida Cancer Specialist

Fort Myers, Florida, 33908, United States

RECRUITING

RUSH University Medical Center

Chicago, Illinois, 60612, United States

TERMINATED

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Karmanos

Detroit, Michigan, 48201, United States

TERMINATED

Memorial Sloan Kettering Cancer Center

New York, New York, 07920, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Providence Portland Medical Centre

Portland, Oregon, 97213, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Washington University

Seattle, Washington, 63130, United States

RECRUITING

Seattle Cancer Care / Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

RECRUITING

Assistance publique - Hôpitaux de Marseille

Marseille, Bouches-du-Rhône, France

RECRUITING

Center Bergonié

Bordeaux, Gironde, France

RECRUITING

Institut Gustave-Roussy

Villejuif, Paris, France

RECRUITING

Centre François Baclesse

Caen, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Charité Comprehensive Cancer Center

Berlin, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

Hospital Universitario de A Coruña

A Coruña, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

University Hospital October 12

Madrid, 28041, Spain

RECRUITING

Hospital Madrid Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Virgen de la Victoria de Malaga

Málaga, 29010, Spain

RECRUITING

Tawam Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

RECRUITING

Sheik Shakhbout Medical City (SSMC)

Abu Dhabi, 11001, United Arab Emirates

RECRUITING

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, 112412, United Arab Emirates

RECRUITING

University College London Hospital

London, NW1 2BU, United Kingdom

RECRUITING

Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW36JJ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust - Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

RECRUITING

Central Study Contacts

Clinical Trials Team

CONTACT

+44 20 3743 0992; Enquires@ellipses.life

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 5, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

FR (5); IT (1); GB (5); AE (3); ES (7); US (18); DE (1)