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

NCT ID NCT07630974

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 20 times

Summary

This study tests a drug called ifinatamab deruxtecan (I-DXd) in children with solid tumors that have returned or not responded to treatment. The drug is an antibody-drug conjugate that targets cancer cells directly. The trial aims to check safety and see if tumors shrink in about 134 children with specific cancer types.

What this could mean

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

Active substance
ifinatamab deruxtecan (I-DXd)
What this could lead to
If it works, this could offer a new treatment option for children with hard-to-treat solid tumors that have come back or not responded to standard therapy.
What could go wrong
This is an early-phase trial with a small number of children, so results may not apply to all patients. The drug may cause side effects or not shrink tumors as hoped.

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 134 people

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

Started

Jul 2026

Expected to finish

Aug 2031

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: * In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens). * Is an individual of any sex/gender, ≥1 month to \<12 years of age for Part 1 and ≥1 month to \<18 years for Part 2 at the time of providing the informed consent or assent, as applicable * Participants who have 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. The main exclusion criteria include but are not limited to the following: * Has clinically significant corneal disease * Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening * Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease * Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses * Has an active, known or suspected autoimmune disease. * Has history of solid organ transplant. * Has history of allogeneic stem cell transplant (SCT). * Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks * Has history of human immunodeficiency virus (HIV) infection. * Has known additional malignancy that is progressing or has required active treatment within the past 1 year. * Has active infection requiring systemic therapy * Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

cancer neoplasm neuroblastoma osteosarcoma rhabdomyosarcoma Wilms tumor

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

    26 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

  • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)

    RECRUITING

    Seoul, 05505, South Korea

  • Bordeaux University Hospital - Pellegrin ( Site 4105)

    RECRUITING

    Bordeaux, Aquitaine, 33076, France

  • CENTRE LEON BERARD ( Site 4100)

    RECRUITING

    Lyon, Rhone, 69373, France

  • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)

    RECRUITING

    Nantes, Loire-Atlantique, 44093, France

  • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles ( Site 4006)

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia (CHOP) ( Site 4021)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Corewell Health ( Site 4001)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana Farber Cancer Center ( Site 4013)

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hospital Niño Jesús ( Site 4715)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Sant Joan de Déu ( Site 4717)

    RECRUITING

    Esplugues de Llobregat, Barcelona, 8950, Spain

  • Hospital Universitari Vall d Hebron ( Site 4716)

    RECRUITING

    Barcelona, 08035, Spain

  • Intermountain - Primary Children's Hospital ( Site 4014)

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Memorial Sloan Kettering Cancer Center ( Site 4010)

    RECRUITING

    New York, New York, 10065, United States

  • New York Medical College ( Site 4023)

    RECRUITING

    Valhalla, New York, 10595, United States

  • Rambam Health Care Campus ( Site 4674)

    RECRUITING

    Haifa, 3109601, Israel

  • Rigshospitalet ( Site 4467)

    RECRUITING

    Copenhagen, Capital Region, DK-2100, Denmark

  • Rutgers Cancer Institute of New Jersey ( Site 4008)

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Sahlgrenska Universitetssjukhuset ( Site 4634)

    RECRUITING

    Gothenburg, Västra Götaland County, 416 85, Sweden

  • Sanford Children's Hospital ( Site 4015)

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Seoul National University Hospital-Pediatrics ( Site 4972)

    RECRUITING

    Seoul, 03080, South Korea

  • Sheba Medical Center ( Site 4675)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • UZ Gent ( Site 4428)

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • University of Iowa Hospitals ( Site 4017)

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Texas M.D. Anderson Cancer Center ( Site 4007)

    RECRUITING

    Houston, Texas, 77030, United States

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