Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing S… (NCT07297979) | Clinical Trial Compass
RecruitingPhase 1
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
United States, Australia50 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range2 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Performance status:
✓. Karnofsky ≥ 70% for participants ≥ 16 years of age.
✓. Lansky ≥ 70% for participants \< 16 years of age.
✓. Adequate organ function, defined as follows:
✓. Participants of childbearing potential must use protocol-specified contraception to prevent pregnancy during treatment and for an additional 6 months after the last dose of xaluritamig.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only)
Timeframe: Up to 42 days
2
Number of Participants with Treatment-emergent Adverse Events
✕. 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.
✕. Participants who received anti-cancer therapy administered within the following minimum washout periods prior to first dose of xaluritamig:
✕. Cytotoxic chemotherapy: 21 days.
✕. Small molecules including tyrosine kinase inhibitors: 7 days or 5 half-lives, whichever is shorter.
✕. Monoclonal antibodies, immune checkpoint inhibitors, bispecific antibodies and other biologic agents: 28 days or 5 half-lives, whichever is shorter.