Status:
RECRUITING
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Lead Sponsor:
Vir Biotechnology, Inc.
Conditions:
Hormone-refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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) a...
Detailed Description
Duration of the study up to approximately 48 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2027
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT05997615
Start Date
August 10 2023
End Date
September 29 2027
Last Update
September 24 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number: 100
Melbourne, Australia, 3000
2
Investigational Site Number: 101
Sydney, Australia, 2010
3
Investigational Site Number: 251
Barcelona, Spain, 08023
4
Investigational Site Number: 250
Barcelona, Spain, 08035