NCT05997615PHASE1RECRUITING1 endpoint open for prediction

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

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

Sponsor: Vir Biotechnology, Inc.

Open for Predictions · 1 endpoint

NCT05997615Objective Response Rate (ORR %)Primary

The percentage of patients with confirmed complete or partial response per RECIST 1.1. Higher is better.

Prediction range: 0 – 100 %

Key Facts

Study type

INTERVENTIONAL

Conditions

Hormone-refractory Prostate Cancer

Interventions

VIR-5500, Enzalutamide, Darolutamide

Enrollment

390 participants

Primary completion

Sep 2027

Study completion

Sep 2027

First posted

Aug 2023

Last updated

Apr 2026

Primary Endpoints (CT.gov)

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

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

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

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

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

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

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

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

Secondary Endpoints

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

Part 1 and 3a: PSA response rate

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

Eligibility Criteria

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) * 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 m…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov

Related Program

VIR-5500

Vir Biotechnology, Inc. / Astellas

View program page →