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VIR-5500 for Hormone-Refractory Prostate Cancer

This study is looking at a new treatment called VIR-5500 (AMX-500) for men with hormone-refractory prostate cancer (prostate cancer that has stopped responding to hormone therapy). Researchers want to learn about the safety of VIR-5500, how it moves through the body, and if it helps shrink tumors or slow down cancer growth. The study will test VIR-5500 by itself and in combination with another prostate cancer drug called an ARSI (androgen receptor signaling inhibitor). You might be able to join if you are a man aged 18 or older with metastatic prostate cancer that has progressed. The study aims to enroll 437 participants, but its current status is unclear.

Study design
This is an interventional study with 437 planned participants. It will be conducted in four parts, starting with testing VIR-5500 alone, then in combination with an ARSI.
What's involved
The study duration is up to approximately 48 months. You will receive VIR-5500 as an intravenous (IV) infusion, and potentially an ARSI orally.
Compensation
Not stated in the trial record.
Follow-up
Your safety and PSA (Prostate-Specific Antigen) response will be measured for up to approximately 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05997615

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Astellas Pharma Global Development, Inc.
~437 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:VIR-5500Androgen receptor signaling inhibitor (ARSI)

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500
Measured over from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
+4 more outcomes measured

Conditions

Hormone-refractory Prostate Cancer

Explore related trials

Hormone sensitive prostate cancerMetastatic Castration-Resistant Prostate CarcinomaNon-metastatic prostate cancerProstate Carcinoma

Where it's being run

12 sites across 7 states
Spain5
Australia2
California1
Texas1
Virginia1
Washington1
United Kingdom1

Who to contact

Study Inquiry
[email protected]
415-654-5281
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.

What this trial measures

  • All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

    Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  • Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs)from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28

    Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  • Part 2 and 4a: Prostate-Specific Antigen (PSA) response ratefrom the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
  • Part 2 and 4a: Objective Response Rate (ORR)from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
  • Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs)from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

    Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)