Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
← catalyst calendarNCT05734066 · readout in 527 d
Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →. With Jazz Pharmaceuticals Ireland Limited.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
60estimated
Sites
15
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-23 | actual | When the study began enrolling |
| Primary completion | 2028-01-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-20 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Refractory Ewing Sarcoma
- Relapsed Ewing Sarcoma
- Ewing Sarcoma
Intervention
- Drug: Lurbinectedin — also filed as JZP712
Primary outcomes
what the primary-completion date above is the date OFPhase 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
measured From the first dose through end of Cycle 1 (21 days).
Phase 1: Number of Participants Experiencing Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs)
measured Post-baseline (Day 1) up to approximately 31 months.
Phase 1: Number of Participants With Dose Modifications
measured Post-baseline (Day 1) up to approximately 31 months.
Phase 1: Number of Participants Who Discontinued Study Intervention Due to TEAEs
measured Post-baseline (Day 1) up to approximately 31 months.
Phase 2: Objective Response Rate (ORR) Based on Investigator Assessment (IA)
measured Day -28 up to a total of 13 months postdose.
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