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New hope for Hard-to-Treat cancers: Next-Gen RET inhibitor enters human trials

NCT ID NCT05443126

Disease control Sponsor: Ellipses Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a new drug called EP0031 in people with advanced cancers that have a specific genetic change (RET alteration), including non-small cell lung cancer. The trial has two parts: first, finding a safe dose, and then checking if the drug shrinks tumors. About 265 adults will take part across multiple sites.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EP0031 (a next-generation RET inhibitor drug)
What this could lead to
If successful, EP0031 could offer a new treatment option for people with advanced RET-altered cancers, especially those who have stopped responding to existing RET inhibitors.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not prove effective or safe enough for wider use. Side effects are unknown and will be closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 265 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Applicable to all participants: 1. Must be ≥18 years of age, with documented RET-altered NSCLC 2. Participants 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. Measurable disease defined by RECIST v1.1 6. Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy. 7. First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start. Exclusion Criteria: Participants with any of the following will not be included in the study: 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. Participants with active hepatitis B infection or active hepatitis C 7. Participants 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 III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 months 11. Uncontrolled hypertension 12. Corneal ulceration or untreated keratitis at screening

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma RET fusion positive cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor NSCLC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    45 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Assistance Publique - Hôpitaux de Marseille

    RECRUITING

    Marseille, France

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    RECRUITING

    Torino, Italy

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Léon Bérard

    RECRUITING

    Lyon, France

  • Centro di Riferimento Oncologico IRCCS

    RECRUITING

    Aviano, Italy

  • Charité Comprehensive Cancer Center

    RECRUITING

    Berlin, Germany

  • Cleveland Clinic Abu Dhabi (CCAD)

    RECRUITING

    Abu Dhabi, 112412, United Arab Emirates

  • David Geffen School of Medicine at UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • Florida Cancer Specialist

    TERMINATED

    Fort Myers, Florida, 33908, United States

  • Florida Cancer Specialists & Research Institute

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    NOT_YET_RECRUITING

    Milan, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, Italy

  • Georgetown University

    RECRUITING

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

  • Guy's and St Thomas' Hospital NHSFT

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hospital Madrid Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Insular de Gran Canaria

    RECRUITING

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario de A Coruña

    RECRUITING

    A Coruña, Spain

  • Hospital Virgen de la Victoria de Malaga

    RECRUITING

    Málaga, 29010, Spain

  • IRCCSS AOU Bologna

    RECRUITING

    Bologna, Italy

  • Institut Bergonié

    RECRUITING

    Bordeaux, France

  • Institut Gustave Roussy

    RECRUITING

    Paris, France

  • Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Roma, Italy

  • Karmanos

    TERMINATED

    Detroit, Michigan, 48201, United States

  • Ludwig-Maximilians-Universität München (LMU)

    NOT_YET_RECRUITING

    München, Germany

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 07920, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Providence Portland Medical Centre

    RECRUITING

    Portland, Oregon, 97213, United States

  • RUSH University Medical Center

    TERMINATED

    Chicago, Illinois, 60612, United States

  • Sarah Cannon Research Institute

    TERMINATED

    Nashville, Tennessee, 37203, United States

  • Sheffield Teaching Hospitals NHSFT

    WITHDRAWN

    Sheffield, S10 2JF, United Kingdom

  • Sheik Shakhbout Medical City (SSMC)

    RECRUITING

    Abu Dhabi, 11001, United Arab Emirates

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • Tawam Hospital

    RECRUITING

    Al Ain City, Abu Dhabi Emirate, United Arab Emirates

  • The Christie Hospital NHSFT

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Ohio State University - Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHSFT

    RECRUITING

    London, SW36JJ, United Kingdom

  • Thomas Jefferson University

    WITHDRAWN

    Philadelphia, Pennsylvania, 19107, United States

  • University College London Hospital (UCLH)

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University of Kentucky

    TERMINATED

    Lexington, Kentucky, 40506, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Washington - Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, Germany

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Poland

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University - School of Medicine

    RECRUITING

    Seattle, Washington, 63130, United States

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