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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (4 UK sites)
Birmingham Children's Hospital ( Site 3349)
Birmingham B4 6NH, United Kingdom
Royal Victoria Infirmary ( Site 3348)
Newcastle upon Tyne NE1 4PL, United Kingdom
University Hospital of Wales ( Site 3346)
Cardiff CF14 4XW, United Kingdom
Royal Marsden Hospital ( Site 3347)
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
