Phase 1 study for people with Prostate Cancer
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Investigational Site Number: 100 | Melbourne | VIC | Recruiting |
| Investigational Site Number: 101 | Sydney | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 14 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 7 October 2026.
- This page last checked by Voxsanity: 14 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.