Actively Recruiting
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
Led by Amgen · Updated on 2026-05-08
50
Participants Needed
6
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part 1: participants must have evaluable disease as defined by RECIST v1.1
- Part 2: participants must have measurable disease as defined by RECIST v1.1
- Histological or cytological confirmation of Ewing Sarcoma with molecular evidence of EWSR1 translocation with an ETS family gene
- Relapsed or refractory disease after at least 1 chemotherapy regimen including anthracycline and alkylating agent
- Karnofsky performance status 270% for participants aged 16 years or older
- Lansky performance status 270% for participants younger than 16 years
- Adequate organ function including hematological, renal, hepatic, pulmonary, and cardiac function according to specified laboratory and clinical criteria
- Use of protocol-specified contraception for participants of childbearing potential during treatment and for 6 months after last dose
You will not qualify if you...
- Untreated central nervous system metastases or leptomeningeal disease; treated CNS metastases allowed with documented improvement and no progression
- History of other malignancies within 2 years except low-risk malignancy treated curatively with no active disease for over 1 year
- Active autoimmune disease requiring systemic treatment within 2 years or other diseases requiring immunosuppressive therapy during study (exceptions apply)
- Recent treatment with anti-cancer therapies within specified washout periods prior to first dose of xaluritamig
- Requirement for chronic systemic corticosteroids above specified doses or other immunosuppressive therapies unless stopped with tapering 28 days before first dose
- Pregnancy, breastfeeding, or planning pregnancy or breastfeeding during and 6 months after treatment
- Unwillingness to abstain from sperm donation during treatment and 6 months after last dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90995-1752
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
5
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
6
Perth Childrens Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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