RecruitingPhase 1NCT07297979

Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)

A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Xaluritamig in Adult, Adolescent and Pediatric Participants With Relapsed or Refractory Ewing Sarcoma


Sponsor

Amgen

Enrollment

50 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric participants with relapsed or refractory EWS.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called xaluritamig in children, teenagers, and adults with Ewing sarcoma — a rare cancer that typically affects the bones and surrounding tissue — that has returned or is not responding to treatment. **You may be eligible if...** - You have a confirmed diagnosis of Ewing sarcoma with a specific genetic marker (EWSR1 translocation) - Your cancer has returned or is no longer responding to treatment - You have measurable disease (a tumor that can be tracked on scans) - You are in adequate overall health as determined by the study team **You may NOT be eligible if...** - You do not have the required genetic marker in your tumor - You have certain prior treatments that conflict with the study drug - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXaluritamig

Participants will receive xaluritamig via short-term intravenous (IV) infusion.


Locations(3)

University of California Los Angeles

Los Angeles, California, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07297979


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