Status:
RECRUITING
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
1-17 years
Phase:
PHASE1
PHASE2
Brief Summary
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 y...
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)
Eligibility Criteria
Inclusion
- 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 (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
Exclusion
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06941272
Start Date
May 26 2025
End Date
December 30 2030
Last Update
January 9 2026
Active Locations (40)
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1
Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016)
Aurora, Colorado, United States, 80045
2
Johns Hopkins All Children's Hospital ( Site 3025)
St. Petersburg, Florida, United States, 33701
3
University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017)
Iowa City, Iowa, United States, 52242
4
Corewell Health ( Site 3001)
Grand Rapids, Michigan, United States, 49503