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Sponsor: Merck Sharp & Dohme LLC
Conditions: Malignant Neoplasm
Interventions: Patritumab Deruxtecan
Countries: United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia
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
Sex: ALL
Age: 1 Month to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- 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
- Ghent, Oost-Vlaanderen, Belgium
- Porto Alegre, Rio Grande do Sul, Brazil
- Barretos, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- Valparaíso, Valparaiso, Chile
- Medellín, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Montería, Departamento de Córdoba, Colombia
- + 33 more on CT.gov