Purpose

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

Condition

Eligibility

Eligible Ages
Between 1 Month and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patritumab Deruxtecan
Participants receive patritumab deruxtecan via IV infusion on Day 1 of each 3-week cycle until discontinuation or progression.
  • Biological: Patritumab Deruxtecan
    IV Infusion
    Other names:
    • MK-1022
    • HER3-DXd
    • U3-1402

Recruiting Locations

Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
Aurora 5412347, Colorado 5417618 80045
Contact:
Study Coordinator
720-777-1234

University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
Iowa City 4862034, Iowa 4862182 52242
Contact:
Study Coordinator
319-356-2296

Corewell Health ( Site 3001)
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Study Coordinator
616-486-0746

Children's Mercy Hospital ( Site 3024)
Kansas City 4393217, Missouri 4398678 64108
Contact:
Study Coordinator
816-302-6808

Rutgers Cancer Institute of New Jersey ( Site 3008)
New Brunswick 5101717, New Jersey 5101760 08901
Contact:
Study Coordinator
732-235-2465

New York Medical College ( Site 3023)
Valhalla 5142090, New York 5128638 10595
Contact:
Study Coordinator
914-614-4270

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3003)
Fargo 5059163, North Dakota 5690763 58122
Contact:
Study Coordinator
701-234-2000

Children's Hospital of Philadelphia (CHOP) ( Site 3021)
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Study Coordinator
267-425-5544

Sanford Children's Hospital ( Site 3015)
Sioux Falls 5231851, South Dakota 5769223 57117
Contact:
Study Coordinator
605-312-1000

University of Texas-MD Anderson Cancer Center ( Site 3007)
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
713-792-5410

Intermountain - Primary Children's Hospital ( Site 3014)
Salt Lake City 5780993, Utah 5549030 84113
Contact:
Study Coordinator
801-662-4700

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Detailed Description

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.