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OncoMatch/Clinical Trials/NCT07297979

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

Is NCT07297979 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Xaluritamig for ewing sarcoma.

Phase 1RecruitingAmgenNCT07297979Data as of May 2026

Treatment: XaluritamigThe 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Biomarker criteria

Required: EWSR1 translocation with an E26 transformation-specific (ETS) family gene (e.g., FLI1, ERG)

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)

Prior therapy

Min 1 prior line

Must have received: chemotherapy

Relapsed or refractory EWS following at least 1 line of chemotherapy (including treatment with an anthracycline and at least 1 alkylating agent)

Must have received: anthracycline

including treatment with an anthracycline

Must have received: alkylating agent

including treatment with ... at least 1 alkylating agent

Lab requirements

Blood counts

ANC ≥ 1.0 x 10^9/L (no short-acting growth factor within 7 days, no long-acting within 14 days); Platelets ≥ 75 x 10^9/L (no platelet transfusion within 7 days, no platelet stimulating agent within 14 days)

Kidney function

eGFR (MDRD) ≥ 30 mL/min/1.73 m^2 for ≥ 18 years; eGFR (Schwartz 2009) ≥ 30 mL/min/1.73 m^2 for < 18 years

Liver function

AST and ALT ≤ 3 x ULN (or ≤ 5 x ULN for participants with liver metastases); Total bilirubin ≤ 1.5 x ULN (unless related to Gilbert's or Meulengracht disease)

Cardiac function

Left ventricular ejection fraction ≥ 50%. If not measurable, left ventricular fractional shortening ≥ 28%

Adequate organ function, defined as follows: Hematological function: ANC ≥ 1.0 x 10^9/L (no short-acting growth factor within 7 days, no long-acting within 14 days); Platelet count ≥ 75 x 10^9/L (no platelet transfusion within 7 days, no platelet stimulating agent within 14 days). Renal function: eGFR (MDRD) ≥ 30 mL/min/1.73 m^2 for ≥ 18 years; eGFR (Schwartz 2009) ≥ 30 mL/min/1.73 m^2 for < 18 years. Hepatic function: AST and ALT ≤ 3 x ULN (or ≤ 5 x ULN for participants with liver metastases); Total bilirubin ≤ 1.5 x ULN (unless related to Gilbert's or Meulengracht disease). Pulmonary function: Baseline oxygen saturation > 92% in room air at rest and no oxygen supplementation. Cardiac function: Left ventricular ejection fraction ≥ 50%. If not measurable, left ventricular fractional shortening ≥ 28%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California Los Angeles · Los Angeles, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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