Evaluating AMX-500 for advanced prostate cancer
A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer
This study is testing a new drug called AMX-500 to see if it is safe and effective for people with advanced prostate cancer that has spread and doesn't respond to hormone treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Vir Biotechnology, Inc. Industry-sponsored |
| Locations | 10 sites (Houston, Texas and 9 other locations) |
| Trial ID | NCT05997615 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety, pharmacokinetics, and preliminary efficacy of AMX-500 in patients with metastatic castration-resistant prostate cancer (mCRPC). The study is structured in four parts, starting with a dose escalation of AMX-500 as a monotherapy, followed by a dose expansion phase. If successful, the trial may proceed to explore combination therapies. The total duration of the study is expected to be approximately 48 months.
Who should consider this trial
Good fit: Ideal candidates include men with confirmed metastatic castration-resistant prostate cancer who have previously undergone taxane-based therapies.
Not a fit: Patients with specific histopathological features or those with acute infections or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment alternatives.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced prostate cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Applicable to Parts 1 and 2 * Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging * Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide * Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) * Are deemed unsuitable for standard of care Applicable to Part 2 Cohort 1 • Must have received standard-of-care radioligand-based therapies, including PSMA-targeted radiopharmaceutical therapy, such as 177Lu-PSMA-617 Applicable to Part 3a and Part 4a * 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) * Have metastatic HSPC, defined by at least 1 and no more than 5 metastatic lesions with no visceral involvement that are present on baseline CT, MRI, or bone scan imaging * Have biochemical recurrent prostate cancer Exclusion Criteria: * Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components * Has acute or chronic infections * Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500, per the Investigator * Has lesions in proximity of vital organs * 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.
Where this trial is running
Houston, Texas and 9 other locations
- Investigational Site Number: 401 — Houston, Texas, United States (Recruiting)
- Investigational Site Number: 400 — Seattle, Washington, United States (Recruiting)
- Investigational Site Number: 100 — Melbourne, Australia (Recruiting)
- Investigational Site Number: 101 — Sydney, Australia (Recruiting)
- Investigational Site Number: 251 — Barcelona, Spain (Withdrawn)
- Investigational Site Number: 250 — Barcelona, Spain (Recruiting)
- Investigational Site Number: 254 — Madrid, Spain (Recruiting)
- Investigational Site Number: 252 — Madrid, Spain (Recruiting)
- Investigational Site Number: 253 — Pamplona, Spain (Recruiting)
- Investigational Site Number: 300 — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Inquiry
- Email: clinicaltrials@vir.bio
- Phone: 415-654-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.