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Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Led by Vir Biotechnology, Inc. · Updated on 2026-04-20
390
Participants Needed
10
Research Sites
215 weeks
Total Duration
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AI-Summary
What this Trial Is About
The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a). * Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation * Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion * Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide) * Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion o Part 4a (Combination Dose Expansion): VIR-5500 in combination with an ARSI (enzalutamide or darolutamide)
CONDITIONS
Official Title
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Have metastatic prostate cancer with at least one metastatic lesion visible on CT, MRI, or bone scan
- Documented progressive metastatic castration-resistant prostate cancer based on one or more criteria per PCWG3
- Previously treated with at least one second-generation androgen-signaling inhibitor (abiraterone, apalutamide, darolutamide, or enzalutamide)
- Previously treated with at least one taxane chemotherapy regimen (e.g., docetaxel, cabazitaxel)
- Deemed unsuitable for standard of care
- For Part 2 Cohort 1: Must have received standard-of-care radioligand-based therapies including PSMA-targeted radiopharmaceutical therapy such as 177Lu-PSMA-617
- For Parts 3a and 4a: Have metastatic castration-resistant prostate cancer with progressive disease or metastatic hormone-sensitive prostate cancer with 1 to 5 metastatic lesions without visceral involvement, or biochemical recurrent prostate cancer
You will not qualify if you...
- Presence of sarcomatoid, spindle cell, or neuroendocrine small cell tumor features
- Acute or chronic infections
- Medical or inflammatory conditions that increase risk of VIR-5500 toxicity as judged by the investigator
- Lesions near vital organs
- Known active central nervous system metastases or carcinomatous meningitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Investigational Site Number: 401
Houston, Texas, United States, 77030
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2
Investigational Site Number: 400
Seattle, Washington, United States, 98109
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3
Investigational Site Number: 100
Melbourne, Australia, 3000
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4
Investigational Site Number: 101
Sydney, Australia, 2010
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5
Investigational Site Number: 251
Barcelona, Spain, 08023
Withdrawn
6
Investigational Site Number: 250
Barcelona, Spain, 08035
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7
Investigational Site Number: 254
Madrid, Spain, 28027
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8
Investigational Site Number: 252
Madrid, Spain, 28223
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9
Investigational Site Number: 253
Pamplona, Spain, 31008
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10
Investigational Site Number: 300
London, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Inquiry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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