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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT07297979
Phase
PHASE1
Status
Recruiting
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Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xaluritamig — DRUG
    Participants will receive xaluritamig via short-term intravenous (IV) infusion.

Study Details

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.

Key Dates

First listed
Dec 22, 2025
Start date
Apr 8, 2026
Status verified
Jul 2026
Primary completion
May 26, 2030
Completion
May 26, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1 (Dose Confirmation)
    Part 1 will begin with a pre-specified xaluritamig target dose and frequency. Multiple dose levels and/or alternative dose regimens may be explored in parallel to determine 1 or more recommended doses for expansion, which is/are considered safe, based on emerging data.
  • Experimental: Part 2 (Dose Expansion)
    Participants will be treated in Part 2 after the recommended doses for expansion for xaluritamig are determined in Part 1 to further characterize preliminary antitumor activity and safety.

Primary Outcome Measure

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only) [ Time Frame: Up to 42 days ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
University of California Los AngelesLos AngelesCalifornia90995-1752-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Texas MD Anderson Cancer Center· Houston, TX

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