Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
Recruiting · NCT05997615 · Interventional (participants receive a specific treatment) · Lead sponsor: Astellas Pharma Global Development, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
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 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 take part
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)
- 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.
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.
Where it is running
13 locations listed across 4 US states.
- UCI Health Chao Family Comprehensive Cancer Center - Orange, California, United States
- Investigational Site Number: 403 - Palo Alto, California, United States
- Investigational Site Number: 401 - Houston, Texas, United States
- Investigational Site number: 404 - Fairfax, Virginia, United States
- Investigational Site Number: 400 - Seattle, Washington, United States
- Investigational Site Number: 251 - Barcelona, Spain
- Investigational Site Number: 250 - Barcelona, Spain
- Investigational Site Number: 300 - London, United Kingdom
- Investigational Site Number: 254 - Madrid, Spain
- Investigational Site Number: 252 - Madrid, Spain
- Investigational Site Number: 100 - Melbourne, Australia
- Investigational Site Number: 253 - Pamplona, Spain
- Investigational Site Number: 101 - Sydney, Australia