Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-500 in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Last updated: July 14, 2025
Sponsor: Vir Biotechnology, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

AMX-500

AMX-500 (SAR446329)

Clinical Study ID

NCT05997615
TCD17896
2023-503495-24
AMX-500-001
U1111-1287-6968
  • Ages > 18
  • Male

Study Summary

The study will be conducted in 4 parts and will commence with dose escalation of AMX-500 as a monotherapy (Part 1), followed by monotherapy dose expansion (Part 2).

  • Part 1 (Monotherapy Dose Escalation): Single-agent AMX-500 dose escalation

  • Part 2 (Monotherapy Dose Expansion): Single-agent AMX-500 dose expansion

The study may subsequently continue via a protocol amendment with dose escalation of AMX-500 combinations (Part 3) followed by combination therapy dose expansion (Part 4).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histological, pathological, and/or cytological confirmation of prostateadenocarcinoma OR metastatic disease typical of prostate cancer (ie, involving boneor pelvic lymph nodes or para-aortic lymph nodes)

  • Has metastatic disease, defined by ≥1 metastatic lesion that is present on baselineCT, MRI, or bone scan imaging - Has documented progressive mCRPC

  • Have been treated with ≥ 1 prior taxane regimens (eg, docetaxel, cabazitaxel)

  • Participants deemed unsuitable for standard of care

  • Has Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

  • Has a life expectancy more than 6 months

Exclusion

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 oftoxicity to AMX 500, per the Investigator

  • Has lesions in proximity of vital organs

  • Has known active CNS metastases and/or carcinomatous meningitis The aboveinformation is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.

Study Design

Total Participants: 215
Treatment Group(s): 2
Primary Treatment: AMX-500
Phase: 1/2
Study Start date:
August 10, 2023
Estimated Completion Date:
September 29, 2027

Study Description

Duration of the study up to approximately 48 months.

Connect with a study center

  • Investigational site number #100

    Melbourne, 3000
    Australia

    Site Not Available

  • Investigational Site Number: 101

    New South Wales, 2010
    Australia

    Active - Recruiting

  • Investigational Site Number: 100

    Victoria, 3000
    Australia

    Active - Recruiting

  • Investigational Site Number: 250

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Investigational Site Number: 251

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Investigational Site Number: 252

    Madrid, 28223
    Spain

    Active - Recruiting

  • Investigational Site Number: 254

    Madrid, 28027
    Spain

    Active - Recruiting

  • Investigational Site Number: 253

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Investigational Site Number: 300

    London, SM2 5PT
    United Kingdom

    Active - Recruiting

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