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New drug targets Hard-to-Treat prostate cancer in early trial

NCT ID NCT03792841

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new drug called acapatamab in 212 men with advanced prostate cancer that had stopped responding to standard hormone therapy and chemotherapy. The drug works by helping the body's immune cells attack cancer cells. The main goals were to check safety and find the best dose, but the study was stopped early.

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

212 people

The number who actually took part.

Started

Feb 2019

Finished

Jun 2023

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.

All Parts Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities/procedures * Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting * Subjects must have undergone bilateral orchiectomy or must be on continuous ADT with a gonadotropin releasing hormone (GnRH) agonist or antagonist * Total serum testosterone \</= 50 ng/dL or 1.7 nmol/L * Evidence of progressive disease, defined as 1 or more PCWG3 criteria: * PSA level \>/= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart * nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications * appearance of 2 or more new lesions in bone scan * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Life expectancy \>/= 6months Exclusion Criteria: * Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for \>/= 30 days prior to randomization are eligible * Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment) * Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression * Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study * Needing chronic systemic corticosteroid therapy (prednisone \> 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha \[TNF alpha\] therapies) unless stopped 7 days prior to start of first dose * Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of acapatamab Part 2 only: * Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing * History or evidence of interstitial lung disease or active, non-infectious pneumonitis Part 3 only: \- Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product Part 6 only: Subjects are excluded from this cohort if any of the following additional criteria apply: * Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg PO QD. * Subjects with latent or active tuberculosis at screening

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Conditions

The condition(s) this trial relates to.

Bites and Stings castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Metastatic castration resistant prostate cancer Prostate cancer

Contacts and locations

Locations

  • BC Cancer Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope at Long Beach Elm

    Long Beach, California, 90813, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • El Camino Hospital

    Campbell, California, 95008, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Krankenhaus der Barmherzigen Brueder Wien

    Vienna, 1020, Austria

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 169610, Singapore

  • National University Hospital

    Singapore, 119074, Singapore

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Peter MacCallum Cancer Centre

    Parkville, Victoria, 3050, Australia

  • Scientia Clinical Research Ltd

    Randwick, New South Wales, 2031, Australia

  • Tulane Medical Center

    New Orleans, Louisiana, 70112, United States

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.