A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Public ClinicalTrials.gov record NCT07630974. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07630974
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 5, 2026
- Primary completion
- Aug 16, 2031
- Completion
- Aug 16, 2031
- Last update posted
- Sep 2, 2026
2026 – 2031
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016) | Aurora | Colorado | 80045 | Recruiting |
| University of Iowa Hospitals ( Site 4017) | Iowa City | Iowa | 52242 | Recruiting |
| Dana Farber Cancer Center ( Site 4013) | Boston | Massachusetts | 02215 | Recruiting |
| Rutgers Cancer Institute of New Jersey ( Site 4008) | New Brunswick | New Jersey | 08901 | Recruiting |
| Memorial Sloan Kettering Cancer Center ( Site 4010) | New York | New York | 10065 | Recruiting |
| New York Medical College ( Site 4023) | Valhalla | New York | 10595 | Recruiting |
| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003) | Fargo | North Dakota | 58102 | Recruiting |
| Children's Hospital of Philadelphia (CHOP) ( Site 4021) | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Sanford Children's Hospital ( Site 4015) | Sioux Falls | South Dakota | 57105 | Recruiting |
| University of Texas M.D. Anderson Cancer Center ( Site 4007) | Houston | Texas | 77030 | Recruiting |
| Intermountain - Primary Children's Hospital ( Site 4014) | Salt Lake City | Utah | 84113 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07630974, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07630974 live on ClinicalTrials.gov.