40 Participants NeededMy employer runs this trial

Xaluritamig for Prostate Cancer

Recruiting at 13 trial locations
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Amgen
Must be taking: Androgen deprivation therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called xaluritamig to determine its safety for individuals with advanced prostate cancer that has spread and no longer responds to standard hormone treatments. The focus is on patients with confirmed prostate cancer and at least one area of metastasis, whose disease has progressed despite previous treatments. Those with worsening prostate cancer who have tried hormone blockers and taxane therapy may qualify for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial requires a minimum 2-week break from certain prostate cancer medications (like enzalutamide, abiraterone, apalutamide, darolutamide) before starting the trial drug. Other medications might also need to be paused, but the protocol doesn't specify all details.

Is there any evidence suggesting that xaluritamig is likely to be safe for humans?

Research has shown that xaluritamig is generally safe for people with prostate cancer. In earlier studies, most patients who took xaluritamig experienced only mild side effects. These studies found that the treatment's safety was manageable, with side effects that were not serious and could be easily controlled. For those considering joining a trial, this suggests that xaluritamig is well-tolerated, with a low risk of serious side effects.12345

Why do researchers think this study treatment might be promising?

Xaluritamig is unique because it represents a new approach to treating prostate cancer by targeting specific proteins involved in cancer cell growth, which is different from traditional treatments like hormone therapy or chemotherapy. Researchers are excited about Xaluritamig because it has the potential to be more precise, offering targeted action with potentially fewer side effects. This new mechanism of action could lead to more effective management of prostate cancer, particularly for patients who have not responded well to existing options.

What evidence suggests that xaluritamig might be an effective treatment for prostate cancer?

Research has shown that xaluritamig is promising for treating advanced prostate cancer that no longer responds to hormone therapy. In one study, 49.3% of patients maintained stable disease, meaning their cancer did not worsen. The treatment also controlled the cancer for a significant period. Xaluritamig aids the immune system in attacking cancer cells. Early data suggest it is more effective than some other prostate cancer treatments. Overall, xaluritamig demonstrated promising results and manageable side effects in early studies.13567

Who Is on the Research Team?

M

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults with metastatic castration-resistant prostate cancer (mCRPC) who have confirmed adenocarcinoma, signs of disease progression, low testosterone levels due to treatment or surgery, and have previously tried at least one hormone therapy and one taxane chemotherapy.

Inclusion Criteria

I have prostate cancer confirmed as adenocarcinoma only.
I have metastatic prostate cancer with at least one lesion seen on recent imaging.
* Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive xaluritamig at the proposed regimen until disease progression or discontinuation

Up to 3.6 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Xaluritamig

Trial Overview

The study is testing the safety of a new drug called xaluritamig in people with advanced prostate cancer that has spread and no longer responds to standard hormone treatments. All participants receive xaluritamig.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Xaluritamig Proposed RegimenExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

ESMO 2024: Xaluritamig, a STEAP1 x CD3 XmAb 2+1 ...

Notably, 49.3% of patients treated with Xaluritamig achieved stable disease. Xaluritamig efficacy. The duration of response was encouraging; however, the data ...

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 as ...

Trial in progress (XALute): Phase 3 study of xaluritamig vs ...

In a first-in-human study, xaluritamig demonstrated encouraging efficacy and a manageable safety profile for patients with mCRPC refractory to ...

Xaluritamig: a first step towards a new target, new mechanism ...

We fully agree with their perspective that xaluritamig holds significant promise as a potential first-in-class T-cell engager in the prostate cancer treatment ...

Bispecific Antibody Shows Preliminary Efficacy in mCRPC

Xaluritamig (AMG 509) demonstrated promising efficacy in patients with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC).

T-Cell Engagers and Xaluritamig in Prostate Cancer Therapy

†10 patients were not PSA evaluable: 6 patients were missing baseline PSA values, and 4 patients did not have sufficient follow-up duration.

NCT04221542 | Study of AMG 509 in Participants With ...

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer