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NCT06941272 · ClinicalTrials.gov registry record · Phase 1
A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)
A Phase 1 study of Malignant Neoplasm, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT06941272: Recruiting Phase 1 study of Malignant Neoplasm, sponsored by Merck Sharp & Dohme.
NCT06941272 is a Phase 1 study of Malignant Neoplasm that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 50 participants, below the 513-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06941272, a Phase 1 study of Malignant Neoplasm, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Conditions Studied
Interventions
- BIOLOGICAL Patritumab Deruxtecan
Study Locations (20)
New York
- Memorial Sloan Kettering Cancer Center ( Site 3010) - New York
- New York Medical College ( Site 3023) - Valhalla
Colorado
- Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 3016) - Aurora
Florida
- Johns Hopkins All Children's Hospital ( Site 3025) - St. Petersburg
Iowa
- University of Iowa Health Care Holden Comprehensive Cancer Center ( Site 3017) - Iowa City
Massachusetts
- Dana-Farber Cancer Institute ( Site 3013) - Boston
Michigan
- Corewell Health ( Site 3001) - Grand Rapids
Missouri
- Children's Mercy Hospital ( Site 3024) - Kansas City
New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 3008) - New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-05-26 |
| Est. Completion | 2030-12-30 |
| Phase | Phase 1 |
What NCT06941272 shows while recruiting
NCT06941272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 513-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Patritumab Deruxtecan is the first listed.
NCT06941272 names 20 study sites across 19 states, led by New York, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06941272 about?
NCT06941272 is a clinical study titled "A Study of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01C/LIGHTBEAM-U01)". 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, bladd...
What is the current status of trial NCT06941272?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-05-26. Estimated completion is 2030-12-30.
What conditions does trial NCT06941272 study?
This clinical trial studies the following conditions: Malignant Neoplasm.
What interventions are being tested in trial NCT06941272?
The interventions under investigation include: Patritumab Deruxtecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT06941272?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06941272 being conducted?
This trial has 20 study locations across Colorado, Florida, Iowa, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06941272's enrollment target sits among peer trials
50 44th of 59 higher than 16 of 59 other Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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