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

ClinicalTrials.gov ID: NCT05734066

Public ClinicalTrials.gov record NCT05734066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Nov 7, 2026, 3:07 PM EST

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Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05734066
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Jazz Pharmaceuticals; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

Lurbinectedin Drug

Drug

Eligibility (public fields only)

Age range: 2 Years to 30 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 23, 2023 (Actual)
Primary completion: Jan 28, 2028 (Estimated)
Completion: Apr 20, 2028 (Estimated)
Last update posted: Nov 5, 2026

2023 – 2028

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Children's Hospital of Los Angeles	Los Angeles	California	90027	Recruiting
Lucile Packard Children's Hospital	Palo Alto	California	94304	Recruiting
Children's National Hospital	Washington D.C.	District of Columbia	20010	Recruiting
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	33701	Recruiting
Children's Healthcare of Atlanta at Arthur M. Blank Hospital	Atlanta	Georgia	30329	Recruiting
Johns Hopkins University	Baltimore	Maryland	21238	Recruiting
Corewell Health	Grand Rapids	Michigan	49503	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
Duke University School of Medicine	Durham	North Carolina	27710	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Nationwide Children's Hospital	Columbus	Ohio	43205	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
St. Jude Children's Research Hospital	Memphis	Tennessee	38105	Recruiting
Children's Health Dallas	Dallas	Texas	75235	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05734066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 5, 2026 · Synced Nov 7, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05734066 live on ClinicalTrials.gov.

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