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

NCT07630974 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-08-10

No results posted yet for this 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

Conditions

  • Malignant Neoplasm

Interventions

BIOLOGICAL

Ifinatamab Deruxtecan

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-02
Primary Completion
2031-08-17
Completion
2031-08-17
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Israel
  • South Korea
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630974 on ClinicalTrials.gov