Study of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Patient Summary

This clinical trial is for patients who have metastatic castration resistant prostate cancer (mCRPC) and failed to respond to abiraterone acetate or enzalutamide (but not both) and to taxane-based chemotherapy. 

This study is investigating the safety and effects (good or bad) of using AMG 509 to treat prostate cancer, which spread to other parts of the body and is resistant to chemo-hormonal therapies.

AMG 509 is an immuno-oncology treatment that may help limit a cancer cell’s ability to grow.  AMG 509 attaches to the patient’s T cells and the prostate cancer cells, with the goal of putting the T cells directly in contact with the prostate cancer cell. 

What is the purpose?

This clinical trial’s objective is to find out when AMG 509 is safe and can slow down or stop the growth of mCPRC. 

What type of therapy is used?

AMG 509 is a type of immunotherapy that incorporates the bispecific T cell recruiting XmAb antibody constructs to fight cancer. This therapeutic design closes the space between the patient’s T cells and prostate cancer, so that the body’s T cells may more efficiently attack prostate cancer cells. 

Who can participate?

To be eligible for this trial, a participant should have evidence of cancer progression while on current anti-androgen therapies or following, such as enzalutamide, abiraterone. In addition, participants must have failed at least 1 chemotherapy (taxane).

Full eligibility criteria

What’s involved?

Participants will receive:

• AMG 509 IV infusion 
• Dexamethasone (or similar corticosteroids) will be given before dosing during cycle 1

Possible patient benefits:  

• This monotherapy could slow down or stop the progression of prostate cancer and potentially prolonging life. 
• Patients will be under close medical supervision for safety during the study period.

Possible patient risks:

• The use of AMG 509 will provide no benefit for preventing disease progression.
• The use of AMG 509 may also cause side-effects.

Clinical Trial Sites:

This is a phase 1 clinical trial that will enroll 70 participants. The trial began March 9, 2020, and the primary completion date is October 22, 2025.  Trial sites are sites that can be found here.

For addition information go to Amgen Med info  

Organization: AMGEN

If you are interested in this trial, review the following: 

• ClinicalTrials.gov Identifier: NCT04221542
• For additional information go to AMGEN  
• Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand. 

Register your interest or comments about this trial with PHEN

PHEN Contact: 617-481-4020

Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.

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