Study on Patritumab Deruxtecan for Children with Relapsed or Hard-to-Treat Solid Tumors
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06941272
This clinical trial is exploring a new treatment, Patritumab Deruxtecan, for children with certain types of cancer that have either returned after treatment or did not respond to previous treatments. The study aims to assess the safety and effectiveness of this treatment in shrinking or eliminating tumors.
Patient Parameters
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Program Overview
Researchers are testing a new treatment called Patritumab Deruxtecan for children with specific cancers that have come back or are difficult to treat. These cancers include hepatoblastoma, a liver cancer common in young children, and rhabdomyosarcoma (RMS), a cancer that starts in muscle cells. The study will evaluate if this treatment is safe for children, how it behaves in their bodies, and whether it can help reduce or eliminate their cancer.
Description
The study is divided into two parts. The first part focuses on ensuring the treatment is safe and determining the best dose for children. The second part will evaluate how well the treatment works in shrinking or eliminating the cancer. Patritumab Deruxtecan is a type of treatment known as an antibody-drug conjugate (ADC), which targets cancer cells and delivers medication directly to them to help destroy the cancer. The study will monitor the children's response to the treatment and any side effects they may experience.
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 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
- 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 (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016) | 80045 | Aurora | Colorado |
| University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017) | 52242 | Iowa City | Iowa |
| Corewell Health ( Site 3001) | 49503 | Grand Rapids | Michigan |
| Children's Mercy Hospital ( Site 3024) | 64108 | Kansas City | Missouri |
| Rutgers Cancer Institute of New Jersey ( Site 3008) | 08901 | New Brunswick | New Jersey |
| New York Medical College ( Site 3023) | 10595 | Valhalla | New York |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003) | 58122 | Fargo | North Dakota |
| Children's Hospital of Philadelphia (CHOP) ( Site 3021) | 19104 | Philadelphia | Pennsylvania |
| Sanford Children's Hospital ( Site 3015) | 57117 | Sioux Falls | South Dakota |
| University of Texas-MD Anderson Cancer Center ( Site 3007) | 77030 | Houston | Texas |
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