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New hope for tough prostate cancer: first human trial of VIR-5500 begins

NCT ID NCT05997615

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 4 times

Summary

This early-stage study tests a new drug called VIR-5500 in people with advanced prostate cancer that has stopped responding to hormone treatment. The main goals are to check the drug's safety and find the right dose, while also seeing if it can shrink tumors or lower PSA levels. About 437 participants will receive VIR-5500 alone or with another therapy.

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

About 437 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

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: Applicable to Parts 1 and 2 1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging 2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications * Appearance of ≥ 2 new lesions in bone scan 3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide 4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) 5. Are deemed unsuitable for standard of care Applicable to Part 2, 3a and Part 4a, 1. Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3): * PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications * Appearance of ≥2 new lesions in bone scan 2. Participants with metastatic hormone sensitive prostate cancer (mHSPC) or with biochemical recurrent prostate cancer (BRPC) may also participate in select cohorts of this clinical trial. Exclusion Criteria: 1. Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components 2. Has acute or chronic infections 3. Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator 4. Has lesions in proximity of vital organs 5. Has known active CNS metastases and/or carcinomatous meningitis The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Genital Diseases hormone-resistant prostate carcinoma male reproductive organ cancer male reproductive system disorder Male Urogenital Diseases metastatic prostate carcinoma neoplasm Neoplasms by Site prostate cancer prostate disorder Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

As listed by the trial registrant

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

Hormone refractory prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number: 100

    RECRUITING

    Melbourne, 3000, Australia

  • Investigational Site Number: 101

    RECRUITING

    Sydney, 2010, Australia

  • Investigational Site Number: 250

    RECRUITING

    Barcelona, 08035, Spain

  • Investigational Site Number: 251

    WITHDRAWN

    Barcelona, 08023, Spain

  • Investigational Site Number: 252

    RECRUITING

    Madrid, 28223, Spain

  • Investigational Site Number: 253

    RECRUITING

    Pamplona, 31008, Spain

  • Investigational Site Number: 254

    RECRUITING

    Madrid, 28027, Spain

  • Investigational Site Number: 300

    RECRUITING

    London, SM2 5PT, United Kingdom

  • Investigational Site Number: 400

    RECRUITING

    Seattle, Washington, 98109, United States

  • Investigational Site Number: 401

    RECRUITING

    Houston, Texas, 77030, United States

  • Investigational Site Number: 403

    RECRUITING

    Palo Alto, California, 94304, United States

  • Investigational Site number: 404

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • UCI Health Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92862, United States

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