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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Xaluritamig

    Drug

    Participants will receive xaluritamig via short-term intravenous (IV) infusion.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Part 1 (Dose Confirmation)Experimental treatment 1 intervention
Group B: Part 2 (Dose Expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only)

Time frame
Up to 42 days
2

Number of Participants with Treatment-emergent Adverse Events

This includes treatment-emergent, treatment-related, serious, and fatal adverse events. Any changes in safety assessments (vital signs and clinical laboratory tests) will be recorded as adverse events.

Time frame
Up to approximately 2.5 years

Secondary outcomes

1

Maximum Serum Concentration (Cmax) of Xaluritamig

Time frame
Up to approximately 6 months
2

Time to Cmax (tmax) of Xaluritamig

Time frame
Up to approximately 6 months
3

Minimum Serum Concentration (Cmin) of Xaluritamig

Time frame
Up to approximately 6 months
4

Accumulation Following Multiple Doses of Xaluritamig

Time frame
Up to approximately 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Source ClinicalTrials.gov
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