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Recruiting

NCT Number: NCT05997615

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

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)

Recruiting

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Key information

Conditions

Hormone-Refractory Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number: 100, Melbourne, Australia

Loading trial locations.

About this study

Duration of the study up to approximately 48 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIR-5500

Drug

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

ARSI

Combination Product

Oral administration

Primary outcomes

  1. Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

    Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  2. Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to Day 21 or Day 28

    Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

  3. Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  4. Part 2 and 4a: Objective Response Rate (ORR)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Secondary outcomes

  1. Part 2 and 4a: Number of participants with Adverse Events (AEs)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  2. Part 1 and 3a: PSA response rate

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  3. Part 1 and 3a: Objective Response Rate (ORR)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  4. All parts: Duration of response (DoR)

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  5. All parts: Progression Free Survival PFS

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  6. All parts: Assessment of PK parameters: Cmax

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  7. All parts: Assessment of PK parameters: AUC

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  8. All parts: Assessment of PK parameters: Tmax

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  9. All parts: Incidence of baseline anti-drug antibodies (ADAs) to VIR-5500

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

  10. All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500

    Time frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Study Inquiry

CONTACT

[email protected]

415-654-5281

Sponsors and collaborators

Lead sponsor

Vir Biotechnology, Inc.

Industry

Registry information

Official study title

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Participants With Prostate Cancer

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2023
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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