Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VIR-5500, ARSI.
- Who it may be relevant to
- Registry conditions: Hormone-refractory Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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)
Detailed description
Duration of the study up to approximately 48 months.
Interventions
- Drug VIR-5500
Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion - Combination product ARSI
Oral administration
Primary outcome measures
- 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]
- 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]
- 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]
- 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 outcome measures (10)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
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)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 5 centers
- Investigational Site Number: 251 — Barcelona
- Investigational Site Number: 250 — Barcelona
- Investigational Site Number: 254 — Madrid
- Investigational Site Number: 252 — Madrid
- Investigational Site Number: 253 — Pamplona
United States · 4 centers
- Investigational Site Number: 403 — Palo Alto
- Investigational Site Number: 401 — Houston
- Investigational Site number: 404 — Fairfax
- Investigational Site Number: 400 — Seattle
Australia · 2 centers
- Investigational Site Number: 100 — Melbourne
- Investigational Site Number: 101 — Sydney
United Kingdom · 1 center
- Investigational Site Number: 300 — London
Identifiers
NCT: NCT05997615 · VIR-5500-V101 · U1111-1287-6968 · 2023-503495-24 · AMX-500