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New targeted therapy shows promise for Hard-to-Treat cancers

NCT ID NCT04262466

Disease control Sponsor: Immunocore Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new drug called brenetafusp for adults with advanced solid tumors that have a specific marker (PRAME) and tissue type (HLA-A*02:01). The drug is designed to help the immune system find and attack cancer cells. The goal is to check if it is safe and if it can shrink or control the cancer. About 410 participants will take part in this early-phase trial.

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

410 people

The number who actually took part.

Started

Feb 2020

Expected to finish

Dec 2027

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: 1. ECOG PS 0 or 1 2. HLA-A\*02:01 positive 3. PRAME positive tumor 4. Relapsed from, refractory to, or intolerant of standard therapies; or, in combination with standard therapies 5. If applicable, must agree to use highly effective contraception Exclusion Criteria: 1. Symptomatic or untreated central nervous system metastasis 2. Recent bowel obstruction 3. Ongoing ascites or effusion requiring recent drainages 4. Significant immune-mediated adverse event with prior immunotherapy (Participants in checkpoint inhibitor combination treatment) 5. Inadequate washout from prior anticancer therapy 6. Significant ongoing toxicity from prior anticancer treatment 7. Out-of-range laboratory values 8. Clinically significant lung, heart, or autoimmune disease 9. Ongoing requirement for immunosuppressive treatment 10. Prior solid organ or bone marrow transplant 11. Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection 12. Significant secondary malignancy 13. Hypersensitivity to study drug or excipients 14. Antibiotics, vaccines or surgery within 2-4 weeks prior to the first dose of study intervention 15. Pregnant or lactating participants 16. Any other contraindication for applicable combination partner based on local prescribing information

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Select advanced solid tumors

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Angeles Clinic and Research Institute

    Los Angeles, California, 90025, United States

  • CHU de Liege

    Liège, Luik, 4000, Belgium

  • CHUM Centre de Recherche

    Montreal, Quebec, H2X 0A9, Canada

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, Switzerland

  • Centrum Medyczne Pratia Poznan - Skorzewo

    Skórzewo, 60-185, Poland

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • D'Or Institute for Research and Education

    Rio de Janeiro, Brazil

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche

    Rome, Roma, 00168, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Patologia Ostetrica e Ginecologica

    Seriate, Roma, 00168, Italy

  • Georgetown University Medical Center

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

  • Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, Val De Marne, 94805, France

  • Guy's and St Thomas' NHS Foundation Trust

    London, United Kingdom

  • Hopital Saint-Louis - Centre d'Onco-Dermatologie

    Paris, 75010, France

  • Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Hospital Israelita Albert Einstein

    São Paulo, Brazil

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, 91350-200, Brazil

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Vall dHebron

    Barcelona, 08035, Spain

  • Houston Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Institut Bergonie - Nouvelle-Aquitaine

    Bordeaux, Gironde, France

  • Institut Curie

    Paris, France

  • Institut Jules Bordet

    Brussels, 1070, Belgium

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

    Naples, 80131, Italy

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020, Austria

  • Leiden UMC

    Leiden, ZA, 2333, Netherlands

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Melanoma Institute Australia (MIA) - The Poche Centre

    Wollstonecraft, New South Wales, 2065, Australia

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • NEXT Barcelona

    Barcelona, 08023, Spain

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Institute

    Rio de Janeiro, Brazil

  • Netherlands Cancer Institute

    Amsterdam, CX, 1066, Netherlands

  • New Zealand Clinical Research-Auckland

    Auckland, 92697, New Zealand

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C4, Canada

  • Prisma Health

    Greenville, South Carolina, 92697, United States

  • Royal Marsden Hospital

    Surrey Quays, SM25PT, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    London, City of London, W1G6AD, United Kingdom

  • Scientia Clinical Research

    Randwick, New South Wales, 2031, Australia

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St Vincents University Hospital

    Dublin, Ireland

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UMC Groningen Comprehensive Cancer Center

    Groningen, GZ, 9713, Netherlands

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • UZA

    Edegem, 2650, Belgium

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Madrid

    Madrid, 28022, Spain

  • Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona

    Pamplona, Navarre, 31008, Spain

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, 1090, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universite Claude Bernard Lyon Est

    Lyon, Villeurbanne, 69100, France

  • University College Hospital London

    London, W1T7HA, United Kingdom

  • University Hospital of Zurich

    Zurich, 8058, Switzerland

  • University Hospital, Basel Switzerland

    Basel, 4031, Switzerland

  • University of California - San Diego

    La Jolla, California, 92093, United States

  • University of California Davis Comprehensive Center

    Sacramento, California, 95817, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Liverpool

    Liverpool, L69 3BX, United Kingdom

  • University of Oklahoma Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Oxford

    Oxford, Oxfordshire, OX3 7LI, United Kingdom

  • University of Ulsan College of Medicine

    Seoul, 05505, South Korea

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • University of Washington - Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • University of Wisconsin

    Madison, Wisconsin, 53705, United States

  • Yonsei University College of Medicine

    Seoul, 03722, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.