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A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

RecruitingPhase 1/2

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

Who can join

1 Month – 17 Years · All sexes

Full eligibility criteria
The main inclusion criteria include but are not limited to the following:

* In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
* Is an individual of any sex/gender, ≥1 month to \<12 years of age for Part 1 and ≥1 month to \<18 years for Part 2 at the time of providing the informed consent or assent, as applicable
* Participants who have 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.

The main exclusion criteria include but are not limited to the following:

* Has clinically significant corneal disease
* Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
* Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
* Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
* Has an active, known or suspected autoimmune disease.
* Has history of solid organ transplant.
* Has history of allogeneic stem cell transplant (SCT).
* Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
* Has history of human immunodeficiency virus (HIV) infection.
* Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
* Has active infection requiring systemic therapy
* Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications

About the study

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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 134 · Started: Jul 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07630974

Locations in the U.S.

CaliforniaChildren's Hospital Los Angeles ( Site 4006), Los Angeles
ColoradoChildren's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016), Aurora
IowaUniversity of Iowa Hospitals ( Site 4017), Iowa City
MassachusettsDana Farber Cancer Center ( Site 4013), Boston
MichiganCorewell Health ( Site 4001), Grand Rapids
New JerseyRutgers Cancer Institute of New Jersey ( Site 4008), New Brunswick
New YorkMemorial Sloan Kettering Cancer Center ( Site 4010), New York
New York Medical College ( Site 4023), Valhalla
North DakotaSanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003), Fargo
PennsylvaniaChildren's Hospital of Philadelphia (CHOP) ( Site 4021), Philadelphia
South DakotaSanford Children's Hospital ( Site 4015), Sioux Falls
TexasUniversity of Texas M.D. Anderson Cancer Center ( Site 4007), Houston
UtahIntermountain - Primary Children's Hospital ( Site 4014), Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.