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

NCT05997615 · tracked via the Priya Life Science UK tracker

Sponsor

Astellas Pharma Global Development, Inc.

Phase

Phase 1

Started

2023-08-10

Last updated

2026-09-10

Condition(s) studied

Hormone-refractory Prostate Cancer

Investigational drug(s) / intervention(s)

VIR-5500Androgen receptor signaling inhibitor (ARSI)

VIR-5500: Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion

Androgen receptor signaling inhibitor (ARSI): Oral administration

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 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)

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Applicable to Parts 1 and 2 1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging 2. 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 3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide 4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) 5. Are deemed unsuitable for standard of care Applicable to Part 2, 3a and Part 4a, 1. 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 2. 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: 1. Presence of dominant histopathological features representative of sarcomatoid, spindle cell, or neuroendocrine small cell components 2. Has acute or chronic infections 3. Has a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5500 (AMX-500), per the Investigator 4. Has lesions in proximity of vital organs 5. 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.

Primary outcome measure(s)

All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500 — 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)
Part 1 and 3a: Incidence of Dose Limiting Toxicities (DLTs) — 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)
Part 2 and 4a: Prostate-Specific Antigen (PSA) response rate — from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
Part 2 and 4a: Objective Response Rate (ORR) — from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months
Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs) — 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)

Trial sites (13)

Facility	City	Region	Status
UCI Health Chao Family Comprehensive Cancer Center	Orange	California	Recruiting
Investigational Site Number: 403	Palo Alto	California	Recruiting
Investigational Site Number: 401	Houston	Texas	Recruiting
Investigational Site number: 404	Fairfax	Virginia	Recruiting
Investigational Site Number: 400	Seattle	Washington	Recruiting
Investigational Site Number: 100	Melbourne	Australia	Recruiting
Investigational Site Number: 101	Sydney	Australia	Recruiting
Investigational Site Number: 251	Barcelona	Spain	Withdrawn
Investigational Site Number: 250	Barcelona	Spain	Recruiting
Investigational Site Number: 254	Madrid	Spain	Recruiting
Investigational Site Number: 252	Madrid	Spain	Recruiting
Investigational Site Number: 253	Pamplona	Spain	Recruiting
Investigational Site Number: 300	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05997615 on ClinicalTrials.gov ↗ ← All trials in the UK