Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Recruiting now · Phase 1

Conditions studied: Hormone-refractory Prostate Cancer

In brief

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)

Key facts

Study ID

NCT05997615

Run by

Vir Biotechnology, Inc.

People needed

437

Starts

2023-08-10

Expected to finish

2027-09-29

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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 patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number: 403 — Palo Alto, California, United States (enrolling)
• Investigational Site Number: 401 — Houston, Texas, United States (enrolling)
• Investigational Site number: 404 — Fairfax, Virginia, United States (enrolling)
• Investigational Site Number: 400 — Seattle, Washington, United States (enrolling)
• Investigational Site Number: 100 — Melbourne, Australia (enrolling)
• Investigational Site Number: 101 — Sydney, Australia (enrolling)
• Investigational Site Number: 300 — London, United Kingdom (enrolling)
• Investigational Site Number: 250 — Barcelona, Spain (enrolling)
• Investigational Site Number: 254 — Madrid, Spain (enrolling)
• Investigational Site Number: 252 — Madrid, Spain (enrolling)
• Investigational Site Number: 253 — Pamplona, Spain (enrolling)
• Investigational Site Number: 251 — Barcelona, Spain

Full record on ClinicalTrials.gov

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