A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)

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

  • Malignant Neoplasm

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).