Approval Probability
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Adjusted LOA
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Xaluritamig · 7 trials · 8 indications
This will include treatment-emergent adverse events, serious adverse events, treatment-related adverse events, and fatal adverse events.
Inclusive of adverse events, serious adverse events, and changes in vital signs and clinical laboratory tests.
Events categorized as adverse events (AEs) starting on or after first dose of investigational product (xaluritamig) as determined by the flag indicating if the AE started prior to the first dose on the Events Electronic Case Report Form (eCRF) and including 30 days after the last dose of investigational product (xaluritamig) or end of study date, whichever is earlier.
A TRAE is any TEAE that per investigators' review has a reasonable possibility of being caused by the investigational product (xaluritamig) determined by the flag indicating an event may have been caused by the investigational product (xaluritamig) on the Events eCRF. In the unlikely event that the flag is missing, the TEAE will be considered related.
| Arm | Type | Description |
|---|---|---|
| Xaluritamig Plus Abiraterone | EXPERIMENTAL | Participants will be randomized to receive xaluritamig in combination with abiraterone acetate. |
| Investigator's Choice | ACTIVE_COMPARATOR | Participants will receive investigator's choice of: * Abiraterone acetate orally, once daily or * Docetaxel IV Q3W or * Cabazitaxel IV Q3W. |
| Xaluritamig | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion. |
| Cabazitaxel/Abiraterone/Enzalutamide | ACTIVE_COMPARATOR | Participants with mCRPC will be randomized to receive cabazitaxel as an IV infusion, or a second androgen receptor-directed therapy of either abiraterone as oral tablets, or enzalutamide as oral tablets at the investigator's discretion. |
| Xaluritamig Proposed Regimen | EXPERIMENTAL | Participants will be dosed at the proposed regimen until disease progression or discontinuation of study treatment. |
| Part 1 (Dose Confirmation) | EXPERIMENTAL | 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. |
| Part 2 (Dose Expansion) | EXPERIMENTAL | 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. |
| Xaluritamig with Darolutamide | EXPERIMENTAL | Participants will receive xaluritamig in combination with darolutamide. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. |
| Xaluritamig with Abiraterone | EXPERIMENTAL | Participants will receive xaluritamig in combination with abiraterone. Participants will enter long-term follow-up for up to 3 years from the first dose of study treatment, or until withdrawal of consent, lost to follow-up, or participant death, whichever occurs first. |
| Cohort A - Xaluritamig | EXPERIMENTAL | Xaluritamig will be administered prior to radical prostatectomy. |
| Cohort B - Xaluritamig with an Oral GnRH Antagonist | EXPERIMENTAL | Xaluritamig will be administered prior to radical prostatectomy. Participants will also receive an oral GnRH antagonist continuously up to the time of planned radical prostatectomy. |
| Name | Type | Description |
|---|---|---|
| Xaluritamig | DRUG | Xaluritamig will be administered IV. |
| Abiraterone acetate | DRUG | Abiraterone acetate will be administered orally. |
| Docetaxel | DRUG | Docetaxel will be administered IV. |
| Cabazitaxel | DRUG | Cabazitaxel will be administered IV. |
| Abiraterone | DRUG | Oral tablets |
| Enzalutamide | DRUG | Oral tablets |
| Darolutamide | DRUG | Participants will receive darolutamide orally. |
| GnRH Antagonist | DRUG | Oral administration |
Inclusion Criteria: * Participant has provided informed consent before initiation of any study-specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participant must have histological, patholo...
Xaluritamig is an investigational oncology therapy being studied for several prostate cancer indications, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). It is also being evaluated in relapsed or refractory Ewing sarcoma. The drug is in clinical development and is not yet approved.
Xaluritamig is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. Amgen is conducting multiple clinical trials to evaluate the safety and efficacy of Xaluritamig across different cancer types.
Xaluritamig is in Phase 1 and Phase 3 clinical trials. It is an investigational drug, meaning it has not received regulatory approval and is still being studied for safety and effectiveness in patients with prostate cancer and Ewing sarcoma.
Xaluritamig is being studied in several trials, including NCT06691984, a Phase 3 study comparing it to cabazitaxel or second androgen receptor-directed therapy in progressive mCRPC. NCT07213674 is a Phase 3 trial combining Xaluritamig with abiraterone. NCT07140900 is a Phase 1 combination study in mHSPC, and NCT07297979 evaluates it in Ewing sarcoma.
Yes, Xaluritamig is being evaluated in combination with androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer. A Phase 3 trial is also studying Xaluritamig plus abiraterone versus investigator's choice in chemotherapy-naïve metastatic castration-resistant prostate cancer.
The Xaluritamig clinical program includes trials with total enrollment of 1,457 participants. The studies are controlled but not randomized or double-blinded. They are open-label trials enrolling male patients aged 18 years and older for prostate cancer studies, and one trial includes children as young as 2 years for Ewing sarcoma.