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Ewing SarcomaPhase 1NCT07297979

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

A Phase 1 study testing Xaluritamig in people with Ewing Sarcoma, run by Amgen at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Ewing Sarcoma
What is being tested?
Xaluritamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
13 sitesin 2 countries
Study dates
8 Apr 2026to 26 May 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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.
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  • Lansky ≥ 70% for participants < 16 years of age.
  • Adequate organ function, defined as follows:
  • Hematological function: i. Absolute neutrophil count ≥ 1.0 x 109/L, provided that:
  • the participant has not received short-acting growth factor support within 7 days before screening assessment, and
  • the participant has not received long-acting growth factor support within 14 days before screening assessment.
  • Platelet count ≥ 75 x 109/L, provided that:
  • the participant has not received a platelet transfusion within 7 days before screening assessment, and
  • the participant has not received a platelet stimulating agent within 14 days before screening assessment.
  • Renal function: i. Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥ 30 mL/min/1.73 m^2 for participants ≥ 18 years of age.
  • estimated glomerular filtration rate based on Schwartz (2009) calculation ≥ 30 mL/min/1.73 m^2 for participants < 18 years of age.
  • Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for participants with liver metastases).
  • Total bilirubin (TBL) ≤ 1.5 x ULN (unless related to Gilbert's or Meulengracht disease).
  • Pulmonary function: i. Baseline oxygen saturation > 92% in room air at rest and no oxygen supplementation.
  • Cardiac function: i. Left ventricular ejection fraction ≥ 50%. If left ventricular ejection fraction cannot be measured, then left ventricular fractional shortening ≥ 28%.
  • 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.

Who cannot join

  • 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.
  • 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.
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  • Monoclonal antibodies, immune checkpoint inhibitors, bispecific antibodies and other biologic agents: 28 days or 5 half-lives, whichever is shorter.
  • Cellular therapies including Chimeric Antigen Receptor T-cell therapy (CAR-T), adoptive T-cell therapy: 56 days.
  • Radiotherapy: 14 days for focal therapy, 28 days for large field therapy or involving > 30% of the bone marrow.
  • Stem cell transplant: 12 weeks for autologous, 6 months for allogeneic, with no active graft-versus-host disease.
  • Any other therapy or investigational agent: 28 days or 5 half-lives, whichever is longer.
  • Requirement for chronic systemic corticosteroid therapy (prednisone dose > 10 mg/day [> 0.25 mg/kg/day if < 40 kg] or equivalent) or any other immunosuppressive therapies (including anti-tumour necrosis factor α (TNFα) therapies) unless stopped (with adequate tapering) within 28 days before first dose of xaluritamig.
  • Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of trial intervention.
  • Unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of xaluritamig.

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

13 sites in 2 countries

United States10 sites, 10 recruiting

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109-5718

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • University of California Los Angeles

    Los Angeles, California, 90995-1752

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • University of Pittsburgh Medical Center Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Recruiting

  • Mayo Clinic Childrens Center

    Rochester, Minnesota, 55905

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

  • Perth Childrens Hospital

    Nedlands, Western Australia, 6009

    Recruiting

Other trials in Australia

About this study

Official title: 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

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.

Conditions
Ewing Sarcoma
Being tested
Xaluritamig
Keywords
Relapsed or refractory Ewing sarcoma, EWS, Xaluritamig, AMG 509
Medical subject headings
Sarcoma, Ewing, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XaluritamigDrug

    Also called AMG 509

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

Study groups in NCT07297979
Study groupRoleWhat they receive
Part 1 (Dose Confirmation)ExperimentalPart 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.
Receives: Drug: Xaluritamig
Part 2 (Dose Expansion)ExperimentalParticipants 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.
Receives: Drug: Xaluritamig

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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.

    Measured: Up to approximately 2.5 years

Secondary outcomes (16)

  1. Maximum Serum Concentration (Cmax) of Xaluritamig

    Measured: Up to approximately 6 months

  2. Time to Cmax (tmax) of Xaluritamig

    Measured: Up to approximately 6 months

  3. Minimum Serum Concentration (Cmin) of Xaluritamig

    Measured: Up to approximately 6 months

  4. Accumulation Following Multiple Doses of Xaluritamig

    Measured: Up to approximately 6 months

  5. Serum Concentration Before Dosing (Ctrough) of Xaluritamig

    Measured: Up to approximately 6 months

  6. Half-life (t½) of Xaluritamig

    Measured: Up to approximately 6 months

  7. Area Under the Serum Concentration-time Curve (AUC) of Xaluritamig

    Measured: Up to approximately 6 months

  8. Confirmed Objective Response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Up to approximately 6 months

  9. Disease Control per RECIST v1.1

    Measured: Up to approximately 6 months

  10. Time to Response (TTR) per RECIST v1.1

    Measured: Up to approximately 6 months

  11. Duration of Confirmed Response (DOR) per RECIST v1.1

    Measured: Up to approximately 6 months

  12. Progression-free Survival (PFS) per RECIST v1.1

    Measured: Up to approximately 6 months

  13. Time to Progression (TTP) per RECIST v1.1

    Measured: Up to approximately 6 months

  14. Time to First Subsequent Anti-cancer Therapy

    Measured: Up to approximately 6 months

  15. Overall Survival (OS)

    Measured: Up to approximately 2 years

  16. Number of Participants with Anti-xaluritamig Antibody Formation

    Measured: Up to approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start8 Apr 2026
  3. Primary completion26 May 2030 (estimated)
  4. Study completion26 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07297979
Sponsor's protocol ID
20200034
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xaluritamig in people with Ewing Sarcoma, run by Amgen at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only) (time frame: Up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07297979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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