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New hope for kids with tough cancers: targeted drug enters trial

NCT ID NCT06941272

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 4 times

Summary

This study is testing a drug called patritumab deruxtecan in children whose liver or muscle cancers have returned or not responded to treatment. The drug works like a smart bomb, attaching to a protein on cancer cells to deliver a toxic payload. The trial will check if it is safe, how the body processes it, and whether it can shrink tumors.

What this could mean

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

Active substance
patritumab deruxtecan (HER3-DXd)
What this could lead to
If it works, this could offer a new treatment option for children with certain hard-to-treat cancers that have come back or not responded to standard therapy.
What could go wrong
This is an early-phase trial with only 50 children, so it is not yet known if the drug is safe or effective in this age group. Side effects may be significant, and the cancer may still progress.

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 50 people

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

Started

May 2025

Expected to finish

Dec 2030

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

1 month to 17 years

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.

The main inclusion criteria include but are not limited to the following: * Has one of the following histologically confirmed advanced or metastatic solid tumors: Rhabdomyosarcoma (RMS), or Hepatoblastoma * Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens) * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have Grade ≤2 neuropathy are eligible. Participants with Grade ≤2 alopecia are also eligible * Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable The main exclusion criteria include but are not limited to the following: * Has a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD/pneumonitis, or suspected ILD/pneumonitis, or ILD that cannot be ruled out by imaging * Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness * Has a history of solid organ transplant * Has a history of allogeneic stem cell transplant * Has clinically significant corneal disease * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis/leptomeningeal disease; participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks * Has uncontrolled or significant cardiovascular disorder * Has a history of clinically significant congenital cardiac syndrome * Has a history of human immunodeficiency virus (HIV) infection * Has a known additional malignancy that is progressing or has required active treatment within the past 1 year * Has an active infection requiring systemic therapy * Has concurrent active hepatitis B (HBsAg positive and/or detectable HBV deoxyribonucleic acid \[DNA\]) and HCV defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid \[RNA\]) infection * Has not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

cancer hepatoblastoma neoplasm rhabdomyosarcoma

As listed by the trial registrant

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

Malignant neoplasm

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

    63 sites in 23 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

  • Aghia Sophia Children's Hospital-First Department of Pediatrics, National and Kapodistrian Universi ( Site 3797)

    RECRUITING

    Athens, Attica, 11527, Greece

  • Alberta Children's Hospital ( Site 3227)

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Ankara Bilkent Şehir Hastanesi. ( Site 3962)

    RECRUITING

    Ankara, 6800, Turkey (Türkiye)

  • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 3973)

    RECRUITING

    Seoul, 05505, South Korea

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 3102)

    RECRUITING

    Marseille, Bouches-du-Rhone, 13005, France

  • Birmingham Children's Hospital ( Site 3349)

    RECRUITING

    Birmingham, England, B4 6NH, United Kingdom

  • Bordeaux University Hospital - Pellegrin ( Site 3105)

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 3104)

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • Centre Leon-Berard ( Site 3100)

    RECRUITING

    Lyon, Rhone, 69373, France

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia (CHOP) ( Site 3021)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospital ( Site 3024)

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Childrens Hospital Los Angeles ( Site 3006)

    RECRUITING

    Los Angeles, California, 90027, United States

  • Clinica de la Costa S.A.S. ( Site 3924)

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Corewell Health ( Site 3001)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana-Farber Cancer Institute ( Site 3013)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Detska nemocnice FN Brno ( Site 3388)

    RECRUITING

    Brno, Brno-mesto, 613 00, Czechia

  • Ege Universitesi Hastanesi ( Site 3963)

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Fakultni nemocnice v Motole-Klinika detske hematologie a onkologie ( Site 3387)

    RECRUITING

    Prague, Praha 5, 150 00, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 3552)

    RECRUITING

    Milan, 20133, Italy

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3267)

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3264)

    RECRUITING

    Barretos, São Paulo, 14784-400, Brazil

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 3961)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Carlos Van Buren ( Site 3880)

    RECRUITING

    Valparaíso, Valparaiso, 2341131, Chile

  • Hospital Infantil Universitario Nino Jesus ( Site 3715)

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Pablo Tobon Uribe ( Site 3923)

    RECRUITING

    Medellín, Antioquia, 05034, Colombia

  • Hospital Sant Joan de Déu ( Site 3717)

    RECRUITING

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitari Vall d''Hebron ( Site 3716)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital de Clinicas de Porto Alegre ( Site 3265)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • IMAT S.A.S ( Site 3921)

    RECRUITING

    Montería, Departamento de Córdoba, 230002, Colombia

  • Institut Curie ( Site 3101)

    RECRUITING

    Paris, Île-de-France Region, 75248, France

  • Intermountain - Primary Children's Hospital ( Site 3014)

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Johns Hopkins All Children's Hospital ( Site 3025)

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Memorial Sloan Kettering Cancer Center ( Site 3010)

    RECRUITING

    New York, New York, 10065, United States

  • Narodny ustav detskych chorob ( Site 3592)

    RECRUITING

    Bratislava, Bratislava Region, 833 40, Slovakia

  • National Taiwan University Hospital ( Site 3983)

    RECRUITING

    Taiwan, Taipei, 10002, Taiwan

  • New York Medical College ( Site 3023)

    RECRUITING

    Valhalla, New York, 10595, United States

  • Oregon Health and Science University ( Site 3004)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ospedale Infantile Regina Margherita ( Site 3551)

    RECRUITING

    Torino, 10126, Italy

  • Ospedale Pediatrico Bambino Gesù IRCCS ( Site 3553)

    RECRUITING

    Roma, 00165, Italy

  • Prinses Maxima Centrum voor Kinderoncologie ( Site 3510)

    RECRUITING

    Utrecht, 3584 CS, Netherlands

  • Queensland Children's Hospital ( Site 3996)

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Rambam Health Care Campus ( Site 3674)

    RECRUITING

    Haifa, 3109601, Israel

  • Rigshospitalet-Department of paediatrics and adolescent medicine, Section of Paed haem-onc ( Site 3467)

    RECRUITING

    Copenhagen, Capital Region, DK-2100, Denmark

  • Royal Children's Hospital ( Site 3994)

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Royal Marsden Hospital ( Site 3347)

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Royal Victoria Infirmary ( Site 3348)

    RECRUITING

    Newcastle upon Tyne, England, NE1 4PL, United Kingdom

  • Rutgers Cancer Institute of New Jersey ( Site 3008)

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sahlgrenska Universitetssjukhuset ( Site 3634)

    RECRUITING

    Gothenburg, Västra Götaland County, 416 85, Sweden

  • Sanford Children's Hospital ( Site 3015)

    RECRUITING

    Sioux Falls, South Dakota, 57117, United States

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Semmelweis University ( Site 3838)

    RECRUITING

    Budapest, Pest County, 1094, Hungary

  • Seoul National University Hospital-Pediatrics ( Site 3972)

    RECRUITING

    Seoul, 03080, South Korea

  • Sheba Medical Center ( Site 3675)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sydney Children's Hospital-Kids Cancer Centre ( Site 3997)

    RECRUITING

    Sydney, New South Wales, 2031, Australia

  • The Hospital for Sick Children ( Site 3225)

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • UZ Gent ( Site 3428)

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • UniversitaetsklInikum Tuebingen ( Site 3142)

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Hospital of Wales ( Site 3346)

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Texas-MD Anderson Cancer Center ( Site 3007)

    RECRUITING

    Houston, Texas, 77030, United States

  • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 3141)

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Yale New Haven Hospital ( Site 3012)

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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