Patient Summary

This study evaluates safety and the performance of AMG 340 in men with metastatic castrate-resistant prostate cancer (mCRPC).

TNB-585 is a novel bispecific antibody, which binds to PSMA on prostate cancer cells and the CD3 molecule on T-cells (immune cell).  It is used to treat men with mCRPC who have received 2 or more other forms therapy.

What is the purpose?

This trial’s objective is to determine whether AMG 340 can slow down or stop the growth of mCRPC. There are two (2) parts to the clinical trial, (1) increasing dose (Arm A) and (2) expanding dose (Arm B). Once the maximum dose is determined, Arm B will begin to further determine how safe and how well an individual can handle the treatment.

What type of therapy is used?

AMG 340 is a type of immune therapy, which stimulates the body's immune cells to attack prostate cancer cells. This bispecific antibody is a targeted therapy, which binds to both the cancer cells and T cells at the sametime, thereby closing the space between the patient’s T cells and prostate cancer. This property of the drug allows the body’s T cells to attack prostate cancer cells more efficiently.

Who can participate?

This phase 1 clinical trial plans to enroll 72 men, beginning April 29, 2021, and scheduled to end March 2022 (primary trial) with completion of the full trial in March 2023.

Who is eligible?

Men who have confirm history mCRPC, which has been demonstrate not to proceeding after receiving two different systemic therapies.

It is suggested that this be discussed with the clinical trial site.

Full eligibility criteria

What’s involved?

Participants will receive:

·        AMG 340 by IV infusion alone

Possible patient benefits 

·        This therapy could slow and stop the progression of prostate cancer and potentially prolong life.

·        Patients will be under close medical supervision for safety during the study period.

Possible patient risks:  

·        The use of AMG 340 will provide no benefit for preventing disease progression in these patients.

·        The use of AMG 340 may also cause side effects.

Clinical Trial Site

Trial sites can be found here.

Organization: AMGEN

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

ClinicalTrials.gov Identifier: NCT04740034

●       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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