Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05443126

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

Led by Ellipses Pharma · Updated on 2026-02-03

265

Participants Needed

40

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be 18 years of age or older with documented RET-altered cancers
  • Patients should be informed and consented about alternative treatment options including approved RET-targeted therapies
  • ECOG performance status of 0 or 1 and life expectancy greater than 3 months at screening
  • Ability to understand and provide written informed consent and participate in all required evaluations and procedures
  • Additional cohort-specific criteria apply
Not Eligible

You will not qualify if you...

  • Any known major driver gene alterations other than RET
  • Spinal cord compression or brain metastases (except stable brain metastases)
  • Active infection requiring systemic antibiotic, antifungal, or antiviral medication
  • Severe or uncontrolled medical or psychiatric conditions
  • Chronic glomerulonephritis or renal transplant
  • Active hepatitis B or hepatitis C infection
  • Active HIV infection (unless adequate CD4+ count and no AIDS-defining infections in past 12 months)
  • Receipt of any strong inhibitor or inducer of CYP3A4
  • Impaired liver or kidney function, inadequate bone marrow reserve or organ function
  • Clinically important ECG abnormalities or recent serious heart conditions
  • Uncontrolled hypertension
  • Corneal ulceration at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

David Geffen School of Medicine at UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

2

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

3

Georgetown University

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

Actively Recruiting

4

Florida Cancer Specialist

Fort Myers, Florida, United States, 33908

Actively Recruiting

5

RUSH University Medical Center

Chicago, Illinois, United States, 60612

Terminated

6

Northwestern University

Evanston, Illinois, United States, 60208

Actively Recruiting

7

University of Kentucky

Lexington, Kentucky, United States, 40506

Actively Recruiting

8

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

9

Karmanos

Detroit, Michigan, United States, 48201

Terminated

10

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 07920

Actively Recruiting

11

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

12

Providence Portland Medical Centre

Portland, Oregon, United States, 97213

Actively Recruiting

13

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

14

Sarah Cannon

Nashville, Tennessee, United States, 37203

Actively Recruiting

15

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

16

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

17

Washington University

Seattle, Washington, United States, 63130

Actively Recruiting

18

Seattle Cancer Care / Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Actively Recruiting

19

Assistance publique - Hôpitaux de Marseille

Marseille, Bouches-du-Rhône, France

Actively Recruiting

20

Center Bergonié

Bordeaux, Gironde, France

Actively Recruiting

21

Institut Gustave-Roussy

Villejuif, Paris, France

Actively Recruiting

22

Centre François Baclesse

Caen, France

Actively Recruiting

23

Centre Léon Bérard

Lyon, France

Actively Recruiting

24

Charité Comprehensive Cancer Center

Berlin, Germany

Actively Recruiting

25

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Actively Recruiting

26

Hospital Universitario de A Coruña

A Coruña, Spain

Actively Recruiting

27

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

28

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Actively Recruiting

29

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

30

University Hospital October 12

Madrid, Spain, 28041

Actively Recruiting

31

Hospital Madrid Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

32

Hospital Virgen de la Victoria de Malaga

Málaga, Spain, 29010

Actively Recruiting

33

Tawam Hospital

Al Ain City, Abu Dhabi Emirate, United Arab Emirates

Actively Recruiting

34

Sheik Shakhbout Medical City (SSMC)

Abu Dhabi, United Arab Emirates, 11001

Actively Recruiting

35

Cleveland Clinic Abu Dhabi (CCAD)

Abu Dhabi, United Arab Emirates, 112412

Actively Recruiting

36

University College London Hospital

London, United Kingdom, NW1 2BU

Actively Recruiting

37

Guy's Hospital

London, United Kingdom, SE1 9RT

Actively Recruiting

38

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW36JJ

Actively Recruiting

39

The Christie NHS Foundation Trust - Christie Hospital

Manchester, United Kingdom, M20 4BX

Actively Recruiting

40

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

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Research Team

C

Clinical Trials Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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