Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
LIGHTBEAM-U01 Substudy 01D: Ifinatamab Deruxtecan in Pediatric Relapsed/Refractory Solid Tumors
NCT07630974Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Aug 2031
- Countries
- 13
- Sponsor
- Merck & Co.
- Conditions
- solid tumorosteosarcoma (OS)neuroblastomarhabdomyosarcoma (RMS)Wilms' tumor
01
Overview
Phase 2, open-label, single-arm trial of ifinatamab deruxtecan in solid tumor, osteosarcoma (OS), neuroblastoma and 2 more, sponsored by Merck & Co. Primary endpoints: Dose-limiting Toxicity at 21 days, Adverse Events at 5 years and 2 more. Started Jul 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Ifinatamab Deruxtecan
Experimental arm receiving ifinatamab deruxtecan
03
Who it enrols
Pediatric participants with recurrent/relapsed, refractory solid tumors (excluding primary CNS) for Part 1, and specific solid tumors (osteosarcoma, neuroblastoma, rhabdomyosarcoma, Wilms tumor) for Part 2, who have progressed after at least 1 prior line of therapy.
04
Endpoints
Primary
Dose-limiting Toxicity
Adverse Events
Objective Response Rate
Disease Control Success at 4 Months
Secondary
Duration of Response
Disease Control Rate
Time to Response
Progression-free Survival
Overall Survival
Pharmacokinetics
Antidrug Antibodies
Beyond the preview
Go deeper on NCT07630974.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT07630974.