Xaluritamig for Bone Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called xaluritamig for bone cancer patients, specifically those with Ewing sarcoma (a type of bone and soft tissue cancer) that has recurred or resisted treatment. The main goals are to determine a safe dose and evaluate the treatment's effectiveness. Eligible participants have already undergone at least one chemotherapy treatment and have a specific gene change in their cancer. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I have to stop taking my current medications for the trial?
The trial requires a 'washout period' (time without taking certain medications) for some treatments before starting xaluritamig. For example, you must stop cytotoxic chemotherapy 21 days before, and other treatments like monoclonal antibodies 28 days before. It's best to discuss your specific medications with the trial team to see if they need to be paused.
Is there any evidence suggesting that xaluritamig is likely to be safe for humans?
Research shows that xaluritamig has been tested in patients with prostate cancer and has a manageable safety profile. Most side effects were temporary and reversible. Some patients experienced more serious side effects, such as cytokine release syndrome (CRS), which can cause fever and low blood pressure, but these were uncommon. Overall, the treatment was generally safe for patients. This suggests that xaluritamig is well-tolerated, with no serious side effects consistently linked to the treatment.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about Xaluritamig for bone cancer because it offers a potentially novel mechanism of action compared to current treatments, which typically include surgery, chemotherapy, and radiation therapy. Xaluritamig is designed to specifically target cancer cells in a way that might enhance antitumor activity while minimizing damage to healthy tissues. This specificity could lead to fewer side effects and improved outcomes for patients. Additionally, the treatment's potential to be tailored through dose adjustments could optimize its effectiveness and safety, making it a promising new option in the fight against bone cancer.
What evidence suggests that xaluritamig might be an effective treatment for bone cancer?
Research has shown that xaluritamig may help treat cancers by targeting certain proteins on cancer cells. In earlier studies, this treatment proved more effective than similar therapies for prostate cancer, with about 49.3% of patients experiencing stable disease, meaning their cancer did not worsen. Additionally, the treatment worked relatively quickly. While these results are promising, they come from trials on prostate cancer, not bone cancer. This trial will explore xaluritamig for bone cancer, with Part 1 focusing on dose confirmation and Part 2 on dose expansion to further characterize its antitumor activity and safety. The mechanism of xaluritamig suggests it might also benefit other cancers, such as bone cancer.13678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults, teens, and children with Ewing sarcoma that has come back or not responded to treatment. Participants must have good physical function, confirmed EWSR1 translocation in their tumor, and have tried at least one prior chemotherapy regimen.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Confirmation
Participants receive xaluritamig at pre-specified target doses to determine safe doses for expansion
Dose Expansion
Participants are treated with the recommended doses to further characterize antitumor activity and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Xaluritamig
Trial Overview
The study is testing different doses of a new drug called xaluritamig to find the safest dose and see how well it works in people with relapsed or refractory Ewing sarcoma. The trial includes both dose-finding and safety evaluation phases.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Xaluritamig, a STEAP1 × CD3 XmAb 2+1 Immune Therapy for ...
The preliminary efficacy results observed with xaluritamig are numerically higher than those reported for other TCEs in prostate cancer (7, 8, 17). Efficacy ...
2.
humanforschung-schweiz.ch
humanforschung-schweiz.ch/de/studiensuche/studien-detail/66822/translate/en/?cHash=d0ee83872acfc6960b54ec572fd19fb420230005 A Phase III Study of Xaluritamig Compared to ...
Xaluritamig is based on preclinical data and clinical evidence for efficacy with a manageable safety profile in patients with mCRPC (first-in-human study).
Study Details | NCT07297979 | Evaluation of Xaluritamig in ...
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the ...
ESMO 2024: Xaluritamig, a STEAP1 x CD3 XmAb 2+1 ...
Kelly presented the initial results from a dose expansion cohorts in a phase 1 study exploring Xaluritamig, a STEAP1 x CD3 XmAb 2+1 ImmuneTherapy, in Patients ...
Clinical Trials Using Xaluritamig - NCI
Clinical Trials Using Xaluritamig. Review the clinical trials studying xaluritamig on this list and use the filters to refine the results by age and location.
NCT07140900 | Study Evaluating the Safety, Tolerability, ...
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway ...
7.
ctv.veeva.com
ctv.veeva.com/study/study-evaluating-the-safety-tolerability-and-efficacy-of-xaluritamig-in-combination-with-androgenStudy Evaluating the Safety, Tolerability, and Efficacy of ...
The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
Xaluritamig for Prostate Cancer · Info for Participants
The available data did not consistently link any serious side effects to the treatment. This suggests that xaluritamig is generally safe for patients. However, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.