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

NCT05997615 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: VIR-5500-V101U1111-1287-69682023-503495-24AMX-500
• Study Type: interventional
• Target: 390
• Locations: 4 countries
• Sites: 10

Brief 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 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)

Conditions

Hormone-refractory Prostate Cancer

Keywords

Prostate Cancer; Castration Resistant Prostatic Cancer; Low-Volume Oligometastatic Hormone Sensitive Prostate Cancer (HSPC); High-Risk Biochemical Recurrent Prostate Cancer; Metastatic Castration-resistant Prostate Cancer (mCRPC)

Outcome Measures

Primary Outcomes (4)

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

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

  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)

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

  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

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

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

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

Secondary Outcomes (10)

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

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

• Part 1 and 3a: PSA response rate

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

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

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

• All parts: Duration of response (DoR)

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

• All parts: Progression Free Survival PFS

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

Study Arms (4)

Part 1: VIR-5500 Monotherapy Dose Escalation

EXPERIMENTAL

VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle

Drug: VIR-5500

Part 2: VIR-5500 Monotherapy Dose Expansion

EXPERIMENTAL

VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle

Drug: VIR-5500

Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation

EXPERIMENTAL

Combination Product: Enzalutamide; Combination Product: Darolutamide

Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion

EXPERIMENTAL

Combination Product: Enzalutamide; Combination Product: Darolutamide

Interventions

Darolutamide COMBINATION_PRODUCT

Oral administration

Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation; Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion

VIR-5500 DRUG

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

Part 1: VIR-5500 Monotherapy Dose Escalation; Part 2: VIR-5500 Monotherapy Dose Expansion

Enzalutamide COMBINATION_PRODUCT

Oral administration

Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation; Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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, 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.

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead

Study Sites (10)

Investigational Site Number: 401

Houston, Texas, 77030, United States

RECRUITING

Investigational Site Number: 400

Seattle, Washington, 98109, United States

RECRUITING

Investigational Site Number: 100

Melbourne, 3000, Australia

RECRUITING

Investigational Site Number: 101

Sydney, 2010, Australia

RECRUITING

Investigational Site Number: 251

Barcelona, 08023, Spain

WITHDRAWN

Investigational Site Number: 250

Barcelona, 08035, Spain

RECRUITING

Investigational Site Number: 254

Madrid, 28027, Spain

RECRUITING

Investigational Site Number: 252

Madrid, 28223, Spain

RECRUITING

Investigational Site Number: 253

Pamplona, 31008, Spain

RECRUITING

Investigational Site Number: 300

London, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant

Interventions

enzalutamide; darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Study Inquiry

CONTACT

415-654-5281; clinicaltrials@vir.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 18, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: April 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); US (2); AU (2); GB (1)