A Study of AMG 757 bispecific antibody therapy in men with Neuroendocrine Prostate Cancer (NEPC)

Patient Summary

This study evaluates the safety and the maximum dose that can be handled by patients in this trial.

AMG 757 (tarlatamab) is a half-life extended bispecific T cell engager (HLE BITE®) immuno-oncology therapy that consists of a bispecific antibody that targets DLL3 (Delta-Like Ligand 3). DLL3 is a cell membrane protein that is expressed on the surface of some cancer cells. Tarlatamab helps the patient’s own T cells detect and kill prostate cancer cells that express DLL3.

What is the purpose?

This trial’s objective is to determine and evaluate the safety of the dose of tarlatamab that can be handled by the patient, which has an extended half-life that can slow down or stop the growth of NEPC. The information obtained from this study will assist in the design of future tarlatamab Clinical Trials.

  What type of therapy is used?

Tarlatamab is a type of immunotherapy that stimulates the body's own immune cells to attack the cancer. This antibody which has an extended half-life in the body, is a bispecific, meaning it is a targeted therapy, which binds not only to the cancer cells but also to T cells, closing the space between the patient’s T cells and prostate cancer. This property allows the body’s T cells to attack prostate cancer cells more efficiently.

  Who can participate?

This phase 1 clinical trial plans to enroll 60 participants, beginning June 10, 2021 and scheduled to end March 6, 2023.

To be eligible for this first-in-human study, participants should have metastatic de novo or treatment-emergent NEPC.  Must have histological diagnosis of small cell NEPC by immunohistochemistry or genomic analysis of baseline tumor tissue or circulating tumor DNA. The participants must have life expectancy  >3 months, adequate organ function, and no untreated/symptomatic brain metastasis. The participant must have progressed on at least 1 line of prior systemic treatment.

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

 Full eligibility criteria

 What’s involved?

  • Participants will receive:
    • tarlatamab by IV infusion alone

  Possible patient benefits

  • This therapy could slow and stop the progression of DLL3 expressing 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 tarlatamab may provide no benefit for preventing disease progression in these patients.
  • The use of tarlatamab 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:

 

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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