Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
NCT ID: NCT05997615
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
390 participants
INTERVENTIONAL
2023-08-10
2027-09-29
Brief Summary
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* 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)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: VIR-5500 Monotherapy Dose Escalation
VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle
VIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Part 2: VIR-5500 Monotherapy Dose Expansion
VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle
VIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation
Enzalutamide
Oral administration
Darolutamide
Oral administration
Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion
Enzalutamide
Oral administration
Darolutamide
Oral administration
Interventions
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VIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
Enzalutamide
Oral administration
Darolutamide
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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 Cohort 1
• Must have received standard-of-care radioligand-based therapies, including PSMA-targeted radiopharmaceutical therapy, such as 177Lu-PSMA-617
Applicable to Part 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)
* Have metastatic HSPC, defined by at least 1 and no more than 5 metastatic lesions with no visceral involvement that are present on baseline CT, MRI, or bone scan imaging
* Have biochemical recurrent prostate cancer
Exclusion Criteria
* Has acute or chronic infections
* Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500, 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.
18 Years
MALE
No
Sponsors
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Vir Biotechnology, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number: 100
Melbourne, , Australia
Investigational Site Number: 101
Sydney, , Australia
Investigational Site Number: 251
Barcelona, , Spain
Investigational Site Number: 250
Barcelona, , Spain
Investigational Site Number: 254
Madrid, , Spain
Investigational Site Number: 252
Madrid, , Spain
Investigational Site Number: 253
Pamplona, , Spain
Investigational Site Number: 300
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1287-6968
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-503495-24
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMX-500
Identifier Type: OTHER
Identifier Source: secondary_id
VIR-5500-V101
Identifier Type: -
Identifier Source: org_study_id
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