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
Amgen
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
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Part 1: evaluable disease as defined by RECIST v1.1, as determined by the site investigator. Part 2: measurable disease as defined by RECIST v1.1, as determined by the site investigator. 2. 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). 3. Relapsed or refractory EWS following at least 1 line of chemotherapy (including treatment with an anthracycline and at least 1 alkylati…
Interventions
- DrugXaluritamig
Participants will receive xaluritamig via short-term intravenous (IV) infusion.
Locations (6)
- Cedars Sinai Medical CenterLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Dana Farber Cancer InstituteBoston, Massachusetts
- Chris OBrien LifehouseCamperdown, New South Wales
- Peter MacCallum Cancer CentreMelbourne, Victoria
- Perth Childrens HospitalNedlands, Western Australia