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Looking for participantsPhase1/Phase2

A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06941272

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Patritumab Deruxtecan (biological)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
Patritumab Deruxtecan — biological: IV Infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
1 Month to 17 Years
Who
All
Number of participants
50
Started
2025-05-26
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for malignant neoplasm
  • • Phase1/Phase2 - 50 participants
  • • Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC)

Who can take part?

  • • Ages 1 Month to 17 Years
  • • Diagnosed with malignant neoplasm

Where?

  • • Birmingham - Birmingham Children's Hospital ( Site 3349)
  • • Newcastle upon Tyne - Royal Victoria Infirmary ( Site 3348)
  • • Cardiff - University Hospital of Wales ( Site 3346)
  • • Sutton - Royal Marsden Hospital ( Site 3347)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory: * Hepatoblastoma is a common liver cancer in babies and very young children * RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of HER3-DXd in children and if they tolerate it * What happens to HER3-DXd in children's bodies over time * If children who receive HER3-DXd have the cancer get smaller or go away

More detail

This study will have 2 parts: a safety lead-in to demonstrate a tolerable safety profile and confirm a preliminary recommended phase 2 dose (RP2D) (Part 1) followed by an efficacy evaluation (Part 2)

Malignant Neoplasm

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Month - 17 Years
  • Who can join: All genders

Biomarkers mentioned

HBsAg positive

Treatment history

Treatments you must have had:

  • ✓ recovered to Grade ≤1 or baseline
  • ✓ active treatment within the past 1 year

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has one of the following confirmed by a biopsy advanced or that has spread solid tumors: Rhabdomyosarcoma (RMS), or...
  • ✓Has progressed after at least 1 prior systemic treatment for RMS or hepatoblastoma and who has no satisfactory...
  • ✓Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV)...
  • ✓Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
See the full criteria
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

Where Is This Study? (4 UK sites)

Birmingham Children's Hospital ( Site 3349)

Birmingham B4 6NH, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441213338233

Royal Victoria Infirmary ( Site 3348)

Newcastle upon Tyne NE1 4PL, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0191 282 1014

University Hospital of Wales ( Site 3346)

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+4402921842107

Royal Marsden Hospital ( Site 3347)

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 8642 6011

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10