Safety, Tolerability, Pharmacokinetics, and Efficacy of acapatamab in Subjects With mCRPC

Patient Summary

This study is investigating the safety and effects (good or bad) of using acapatamab alone or with pembrolizumab  (Keytruda) to treat metastatic castration resistant prostate cancer (mCRPC), which has spread to other parts of the body and is resistant to standard hormonal therapies. 

Acapatamab is a bispecific T-cell engager (BiTE®) antibody, which helps the patient’s own T cells detect and kill prostate cancer cells. 

What is the purpose?

This trial’s objective is to find out if acapatamab alone or combined with pembrolizumab is safe and can slow down or stop the growth of mCPRC. The information obtained from this study will assist in the design of future acapatamab studies. 

What type of therapy is used?

Acapatamab is a type of immunotherapy that stimulates the body's immune cells to attack the cancer. It is bispecific, meaning it is a targeted therapy, which binds not only to the cancer but to the T cell, closing the space between the patient’s T cells and prostate cancer. This allows the body’s T cells to more efficiently attack prostate cancer cells. 

Pembrolizumab is also an immunotherapy which blocks cancer’s ability to turn off T cells. The combination of the two immunotherapies (1-2 punch) is believed to slow down or stop cancer growth.

Who can participate?

This phase 1 clinical trial plans to enroll 120 participants, beginning February 5, 2019 and scheduled to end April 15, 2024.

To be eligible for this first-in-human study, participants should have evidence confirming their diagnosis of mCRPC, which is resistant to hormonal therapies (i.e. enzalutamide, abiraterone) and have failed at least 1 chemotherapy (taxane). In addition, participants cannot have an autoimmune disease or diseases that require immunosuppressive therapy during the trial. If participants have taken PD-1- PD-L1 inhibitors or received previous PSMA-targeted therapy, it is suggested that this be discussed with a clinical trial site. 

Full eligibility criteria

What’s involved?

Participants will receive:

  • Acapatamab by IV infusion alone
  • Both acapatamab and pembrolizumab by IV infusion, but at separate times

Possible patient benefits 

  • The combined use of these therapies could include slowing down or stopping 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 acapatamab and pembrolizumab will provide no benefit for preventing disease progression in these patients.
  • The use of acapatamab alone or in combination with pembrolizumab may also cause side-effects.

Clinical Trial Sites:

Trial sites can be found here.

Organization: AMGEN

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

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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