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Tests treatment safety and results for Hormone-refractory Prostate Cancer
Official title Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
ClinicalTrials.gov ID: NCT05997615
What this study is testing
What is VIR-5500?
VIR-5500 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hormone-refractory prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3)
- PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart
- Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications
You likely can't join if
- 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...
See the full eligibility 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)
- PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart
- Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications
- Appearance of ≥ 2 new lesions in bone scan
- 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, 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):
- PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart
- Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications
- Appearance of ≥2 new lesions in bone scan
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Melbourne, Australia
- Sydney, Australia
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Houston, Texas, United States; Fairfax, Virginia, United States; Seattle, Washington, United States; Melbourne, Australia; Sydney, Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.