Phase 1 Prostate Cancer Trial, Recruiting NCT05997615 Sponsor: Vir Biotechnology, Inc. Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT05997615
Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have prostate cancer that has spread to other parts of the body, confirmed by at least one scan (CT, MRI, or bone scan).
  • People whose cancer has continued to grow or spread, shown by rising PSA levels on at least two tests taken a week apart, new or growing tumours on scans, or two or more new spots appearing on a bone scan.
  • People who have previously been treated with at least one newer hormone-blocking medication, such as abiraterone, apalutamide, darolutamide, or enzalutamide.
  • People who have previously received at least one chemotherapy treatment containing a taxane drug, such as docetaxel or cabazitaxel.
  • People whose doctors have determined that standard treatments are no longer appropriate for them.
  • In some specific groups within the trial, people with hormone-sensitive prostate cancer that has spread, or prostate cancer that has returned based on rising PSA levels (without visible spread on scans), may also be considered (confirm with trial site).

Who may not be able to join:

  • People whose prostate cancer has certain unusual cancer cell types, such as sarcomatoid, spindle cell, or small cell neuroendocrine features, seen on a tissue sample.
  • People who currently have an active infection, whether short-term or ongoing.
  • People who have another medical condition or inflammatory illness that the treating doctor believes could increase the risk of side effects from the study treatment.
  • People who have tumours located very close to vital organs.
  • People who have active cancer that has spread to the brain or spinal fluid.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 415-654-5281

Australian sites

Investigational Site Number: 100, Melbourne,
Investigational Site Number: 101, Sydney,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Vir Biotechnology, Inc.
Registry
ClinicalTrials.gov
Start date
10 August 2023
Est. completion
29 September 2027

Where this trial is recruiting

🇦🇺 Australia 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs); Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs); Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate; Part 2 and 4a: Objective Response Rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov