Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer (NCT05997615) | Clinical Trial Compass
RecruitingPhase 1
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
United States, Australia, Spain437 participantsStarted 2023-08-10
Plain-language 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) 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 Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs)
Timeframe: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
2
Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs)
Timeframe: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28
3
Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate
Timeframe: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
4
Part 2 and 4a: Objective Response Rate (ORR)
Timeframe: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
. 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
. 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 (AMX-500), 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.