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NCT07630974 · ClinicalTrials.gov registry record · Phase 1
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT07630974: Recruiting Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT07630974 is a Phase 1 study that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07630974, a Phase 1 study, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
Study Summary
Researchers are looking for new ways to treat children with relapsed or refractory solid tumors: * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids The study treatment I-DXd (also known as MK-2400 or ifinatamab 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 I-DXd and if children younger than 12 years old tolerate it * How many children who receive I-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.
Interventions
- BIOLOGICAL Ifinatamab Deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2026-07-02 |
| Est. Completion | 2031-08-17 |
| Phase | Phase 1 |
What NCT07630974 shows while recruiting
NCT07630974 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 1 intervention - of which Ifinatamab Deruxtecan is the first listed.
NCT07630974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07630974 about?
NCT07630974 is a clinical study titled "A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)". Researchers are looking for new ways to treat children with relapsed or refractory solid tumors: * Relapsed means the cancer came back after treatment * Refractory means the cancer did not respond (get smaller or go away) to treatment * Solid tumors are cancers mostly in body organs and tissues, no...
What is the current status of trial NCT07630974?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2026-07-02. Estimated completion is 2031-08-17.
What interventions are being tested in trial NCT07630974?
The interventions under investigation include: Ifinatamab Deruxtecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT07630974?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07630974's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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