Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
ConditionEwing Sarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2+
SponsorAmgen
About this trial
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 criteria
Qualifiers
Part 1: evaluable disease as defined by RECIST v1.1, as determined by the site investigator.
Histologically or cytologically confirmed EWS with molecular evidence of an EWSR1 translocation with an E26 transformation-specific (ETS) family gene, eg, FLI1, ETS-related gene [ERG]) via next generation sequencing (based on local testing).
Relapsed or refractory EWS following at least 1 line of chemotherapy (including treatment with an anthracycline and at least 1 alkylating agent).
Karnofsky ≥ 70% for participants ≥ 16 years of age.
Disqualifiers
Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
History of other malignancy within the past 2 years, except for malignancy treated with curative intent with low risk for recurrence (approximately < 10%) and with no known active disease present for >1 year before enrollment.
Active autoimmune disease that has required systemic treatment (except physiologic adrenal hormone replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type 1 diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Cytotoxic chemotherapy: 21 days.
Trial design
Treatments tested in this trial
- Xaluritamig
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
7Australia
Chris OBrien Lifehouse2050, CamperdownNew South Wales, Australia
Peter MacCallum Cancer Centre3000, MelbourneVictoria, Australia
Perth Childrens Hospital6009, NedlandsWestern Australia, Australia
United States
Cedars Sinai Medical Center90048, Los AngelesCalifornia, United States
Sponsors and collaborators
Amgen
Lead sponsor
Source ClinicalTrials.gov