MedTrace Logo

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

NCT05997615 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-04-20

No results posted yet for this study

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

o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide)
* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion o Part 4a (Combination Dose Expansion): VIR-5500 in combination with an ARSI (enzalutamide or darolutamide)

Conditions

  • Hormone-refractory Prostate Cancer

Interventions

DRUG

VIR-5500

Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

COMBINATION_PRODUCT

Enzalutamide

Oral administration

COMBINATION_PRODUCT

Darolutamide

Oral administration

Sponsors & Collaborators

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2027-09-29
Completion
2027-09-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997615 on ClinicalTrials.gov