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New treatment option for Ewing Sarcoma
Official title Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
ClinicalTrials.gov ID: NCT07297979
What this study is testing
What is Xaluritamig?
Xaluritamig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ewing sarcoma.
Also referred to as AMG 509.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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...
- Histologically or cytologically confirmed EWS with molecular evidence of an EWSR1 translocation with an E26 transformation-specific (ETS) family...
- 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.
You likely can't join if
- Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if...
- History of other malignancy within the past 2 years, except for malignancy treated with curative intent with low risk for recurrence (approximately \...
- Active autoimmune disease that has required systemic treatment (except physiologic adrenal hormone replacement therapy) within the past 2 years or...
- 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.
See the full eligibility criteria
- 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...
- 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.
- Lansky ≥ 70% for participants \< 16 years of age.
- Adequate organ function, defined as follows: a. 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. ii. 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. b. Renal function: i. Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD)...
- 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.
- 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...
- History of other malignancy within the past 2 years, except for malignancy treated with curative intent with low risk for recurrence (approximately \ 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 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.
- 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...
- 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...
- Unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose of xaluritamig.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Houston, Texas, United States
- Camperdown, New South Wales, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; New York, New York, United States; Houston, Texas, United States; Camperdown, New South Wales, Australia; Melbourne, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.