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New drug shows promise for Tough-to-Treat prostate cancer

NCT ID NCT04702737

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tested a drug called Tarlatamab in 41 men with a rare and aggressive form of prostate cancer called neuroendocrine prostate cancer. The main goal was to check the drug's safety and find the best dose. The drug works by helping the body's immune cells recognize and attack cancer cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tarlatamab (also called AMG 757), a drug that helps immune cells attack cancer cells
What this could lead to
If successful, this could lead to a new treatment option for men with a rare and aggressive form of prostate cancer that currently has few options.
What could go wrong
This is an early phase 1 trial with only 41 participants, focused on safety and dosing. It is too small to prove effectiveness, and side effects may be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

41 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion): * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Men aged ≥ 18 years at time of signing the informed consent. * Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histology, immunohistochemistry, or genomic analyses of baseline tumor tissue (by local assessment) or circulating tumor DNA (ctDNA) (by local assessment) as per protocol * At least 1 line of prior systemic treatment per protocol. * Participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue therapy during the course of protocol therapy * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Participants with treated brain metastases are eligible provided they meet defined criteria * Adequate organ function as defined in protocol Exclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion): * History of other malignancy within the past 2 years, with exceptions: * Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrollment and felt to be at low risk for recurrence by the treating physician * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated non-muscle invasive urothelial carcinoma * History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥ 2 years * Untreated or symptomatic brain metastases and leptomeningeal disease * Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate cancer is permitted; participants on a stable bisphosphonate or denosumab prior to study day 1 are eligible Exceptions: * Participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicities have resolved to Grade ≤ 1 * Prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab * Participants who received androgen signaling inhibitor are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade ≤ 1 * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior study day 1 * Active autoimmune disease requiring systemic treatment within the past 2 years * Known positive test for human immunodeficiency virus (HIV) or hepatitis * Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1 (with the exception of alopecia or toxicities that are stable and well-controlled) * History of hypophysitis or pituitary dysfunction * Has evidence of interstitial lung disease or active, non-infectious pneumonitis. * Participants on prior delta-like ligand 3 (DLL3)-targeted therapy may be eligible if discussed with Amgen Medical Monitor prior to enrollment * Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection unless agreed upon with Medical Monitor and with no acute symptoms of coronavirus disease 2019 (COVID19) disease within 14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic participants).

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Conditions

The condition(s) this trial relates to.

prostate neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroendocrine prostate cancer

Contacts and locations

Locations

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Community Health Network MD Anderson Cancer Center - North

    Indianapolis, Indiana, 46250, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Gustave Roussy

    Villejuif, 94805, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of California at San Francisco Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27103, United States

  • Washington University

    St Louis, Missouri, 63110-1093, United States

  • Weill Cornell Medical College

    New York, New York, 10021, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

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