Trials / Recruiting
RecruitingNCT06941272
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 1 Month – 17 Years
- Healthy volunteers
- Not accepted
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 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
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Patritumab Deruxtecan | IV Infusion |
Timeline
- Start date
- 2025-05-26
- Primary completion
- 2030-12-30
- Completion
- 2030-12-30
- First posted
- 2025-04-23
- Last updated
- 2026-04-13
Locations
59 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06941272. Inclusion in this directory is not an endorsement.