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Also known as xaluritamig
AMG 509 · 8 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. |
| Part 1: AMG 509 Intravenous (IV) Monotherapy | EXPERIMENTAL | Part 1 will evaluate AMG 509 in participants with metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with novel hormonal therapy (NHT) and 1 to 2 prior taxanes. The dose exploration phase of the study will estimate the maximum tolerated dose (MTD) of AMG 509 using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). Recommended phase 2 dose (RP2D) may be identified based on emerging safety, efficacy, PK, and pharmacodynamics (PD) data, as well as patient experience prior to reaching an MTD. Alternative dosing schedule(s) (including a third step dose) may be explored based on emerging efficacy, safety, PK data and patient experience. During the dose-expansion phase, individual cohorts of participants from China will be enrolled with a safety lead-in at 1 dose level below the MTD or RP2D followed by evaluation at the MTD or RP2D to confirm the safety, tolerability, MTD and/or RP2D of AMG 509 in Chinese participants. |
| Part 2: AMG 509 Subcutaneous (SC) Monotherapy | EXPERIMENTAL | Part 2 will explore the safety, tolerability, and PK of AMG 509 SC dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes. Recommended phase 2 dose for SC monotherapy may be identified based on emerging safety, efficacy, PK, and PD data, as well as patient experience prior to reaching an MTD. |
| Part 3: AMG 509 IV Monotherapy in Earlier Lines of Treatment | EXPERIMENTAL | Part 3 will explore AMG 509 in participants with mCRPC who have received no, or 1-2 prior NHTs (may have been given for hormone-sensitive prostate cancer \[HSPC\]) and no prior taxanes (unless administered in HSPC setting). This dose-expansion will be conducted to confirm safety, PK, and PD of AMG 509 at the MTD or RP2D determined in Part 1 dose exploration, and to obtain further safety and efficacy data and correlative biomarker analysis. |
| Part 4: AMG 509 IV Combination Therapy | EXPERIMENTAL | Part 4 will explore the safety, tolerability, and PK of AMG 509 for participants with mCRPC who have received no or 1 to 2 prior NHTs given in any disease setting depending on the part (dose-expansion phase: prior therapies including at least 1 prior NHT and either 0 or 1 prior poly-ADP ribose polymerase \[PARP\] inhibitor), at dose regimens previously determined to be safe and tolerable in Part 1, in combination with abiraterone acetate (Part 4A) or enzalutamide (Part 4B) and no or 1 prior taxane for hormone sensitive disease in Parts 4A and 4B. |
| Part 5: AMG 509 IV Monotherapy in Outpatient Setting | EXPERIMENTAL | Part 5 will evaluate the safety and tolerability of AMG 509 IV dosing in participants with mCRPC who have been previously treated with NHT and 1 to 2 prior taxanes, when administered in outpatient infusion centers. The Part 5 dosing regimen and schedule was selected based on emerging data and dose level review team (DLRT) recommendations and will utilize the doses explored in Part 1 dose-expansion phase. |
| Part 6: AMG 509 IV as Monotherapy and Combination Therapy With Abiraterone Acetate | EXPERIMENTAL | Part 6 will evaluate the preliminary efficacy, safety, tolerability, and PK of AMG 509 (alone or in combination with abiraterone acetate) for participants with mCRPC who have progressed on only 1 prior NHT (prior exposure to ≤ 6 cycles of taxane is allowed in mHSPC setting) and who have Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable disease. Part 6 dosing regimen has been previously determined as safe and tolerable and is aligned with the dosing schedule for Parts 3 and 4A expansion. |
| Part 7 (China only): AMG 509 IV as Monotherapy or in Combination With Abiraterone Acetate | EXPERIMENTAL | Part 7 will only include participants from China. This part will evaluate safety and tolerability of AMG 509 IV dosing in participants who have been previously treated with NHT and 1 to 2 prior taxanes. Part 7 dosing regime will first be enrolled to dose level-1 (1.0 mg target dose) and if tolerated and if DLRT determines it is safe to escalate to the MTD/RP2D, 1.5 mg every 2 weeks (Q2W) dosing regimen may be explored. If the RP2D is safe and tolerable and once AMG 509 monotherapy dose confirmation is complete, a cohort of participants to receive AMG 509 combination therapy with abiraterone acetate may be initiated. |
| 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 |
| AMG 509 | DRUG | AMG 509 administered as an IV infusion (Parts 1, 3, 4 and 5) or SC injection (Part 2). |
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...
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AMG 509 is an investigational therapy being studied for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer. It is in Phase 1 clinical development and is not yet approved for any indication. Amgen Inc. is developing the drug as a potential treatment option for this patient population.
AMG 509 targets B7-H3, an antigen expressed on cancer cells. B7-H3 is a member of the B7 family of immune regulatory proteins and is being explored as a therapeutic target in oncology. By binding to B7-H3, AMG 509 is designed to direct therapeutic activity toward B7-H3-expressing tumor cells in prostate cancer.
AMG 509 is being developed by Amgen Inc., which trades on the Nasdaq under the ticker symbol AMGN. Amgen is a biotechnology company focused on oncology and other therapeutic areas. The company is responsible for the clinical development of AMG 509 in prostate cancer.
AMG 509 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program is evaluating the drug in participants with metastatic castration-resistant prostate cancer.
AMG 509 is being evaluated in a Phase 1 trial, NCT04221542, titled Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer. The trial is currently recruiting, with an estimated enrollment of 479 participants. It is a controlled, randomized study being conducted in the United States, Australia, China, Germany, Japan, Portugal, South Korea, Spain, Switzerland, and Taiwan.