A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Recruiting
Phase 1Phase 2Interventional Study
Malignant Neoplasm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 Month – 17
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for
This trial is looking for children with liver cancer or muscle cancer that has not improved after treatment. Participants will receive a new drug to see if it makes their cancer smaller or go away.
Are You a Good Fit for This Trial?
Rules you outLung diseaseHeart diseaseOrgan transplantActive infection
You may be able to join if
I have been diagnosed with rhabdomyosarcoma or hepatoblastoma.
My cancer has come back or did not respond to previous treatment.
I have recovered from side effects of past cancer treatments.
I have undetectable hepatitis B or C if I had those infections.
I have no other treatment options to improve my cancer.
You may not be able to join if
I have a history of serious lung disease.
I have ongoing problems with my breathing.
I have received an organ transplant.
I have any serious heart problems.
I have an active infection requiring treatment.
I have untreated active hepatitis B or C infections.
I have a current cancer that is being treated.
I have not fully recovered from major surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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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 cance…
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
Trial Locations
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Eligibility 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 h…
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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