NCT05734066

Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants With Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in two phases. The phase 1 portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and effectiveness of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors. This is followed by the phase 2 portion, to further assess the effectiveness and safety in pediatric and young adult participants with recurrent/refractory Ewing sarcoma.

Conditions

• Refractory Ewing Sarcoma
• Relapsed Ewing Sarcoma
• Ewing Sarcoma

Interventions

Type	Name	Description
DRUG	Lurbinectedin	Administered as intravenous (IV) infusion once every 3 weeks (Q3W)

Timeline

• Start date: 2023-05-23
• Primary completion: 2028-01-28
• Completion: 2028-04-20
• First posted: 2023-02-17
• Last updated: 2026-02-03

Locations

15 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study