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New treatment option for Malignant Neoplasm
Official title A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
ClinicalTrials.gov ID: NCT06941272
What this study is testing
What is Patritumab Deruxtecan?
Patritumab Deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for malignant neoplasm.
Also referred to as MK-1022, HER3-DXd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- The main 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...
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. Participants with...
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- The main 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- St. Petersburg, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Kansas City, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Valhalla, New York, United States
- Fargo, North Dakota, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Parkville, Victoria, Australia
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; St. Petersburg, Florida, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.