Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer
- Conditions
- Hormone-refractory Prostate Cancer
- Interventions
- Registration Number
- NCT05997615
- Lead Sponsor
- Vir Biotechnology, Inc.
- 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)
- Detailed Description
Duration of the study up to approximately 48 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 390
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: VIR-5500 Monotherapy Dose Escalation VIR-5500 VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle Part 2: VIR-5500 Monotherapy Dose Expansion VIR-5500 VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day cycle Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation Enzalutamide - Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation Darolutamide - Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion Enzalutamide - Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion Darolutamide -
- Primary Outcome Measures
Name Time Method Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs) from the Cycle 1(each cycle is 21 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 days), Day 1 up to Day 21 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 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 Outcome Measures
Name Time Method 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 All parts: Assessment of PK parameters: Cmax from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months All parts: Assessment of PK parameters: AUC from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months All parts: Assessment of PK parameters: Tmax from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months All parts: Incidence of baseline anti-drug antibodies (ADAs) to VIR-5500 from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months All parts: Incidence of treatment emergent anti-drug antibodies (ADAs) to VIR-5500 from the Cycle 1(each cycle is 21 days), Day 1 up to approximately 48 months
Related Research Topics
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Trial Locations
- Locations (8)
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
Investigational Site Number: 100🇦🇺Melbourne, Australia