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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1287-6968 | Registry Identifier | ICTRP | |
| 2023-503495-24 | Registry Identifier | CTIS | |
| AMX-500 | Other Identifier | Vir Biotechnology, Inc. |
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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).
Duration of the study up to approximately 48 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: VIR-5500 Monotherapy Dose Escalation | Experimental | VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day or 28-day cycle |
|
| Part 2: VIR-5500 Monotherapy Dose Expansion | Experimental | VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day or 28-day cycle |
|
| Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation | Experimental | VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle |
|
| Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion | Experimental | VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-5500 | Drug | Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 or 28 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 or 28 days), Day 1 up to Day 21 or Day 28 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2 and 4a: Number of participants with Adverse Events (AEs) | 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 | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
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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, 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):
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Contact | 415-654-5281 | clinicaltrials@vir.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 403 | Recruiting | Palo Alto | California | 94304 | United States | |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
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| ARSI | Combination Product | Oral administration |
|
| Part 1 and 3a: Objective Response Rate (ORR) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Duration of response (DoR) | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| All parts: Progression Free Survival PFS | 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 | 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 | 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 | 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 | 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 | from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months |
| Investigational Site Number: 401 |
| Recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
| Investigational Site number: 404 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Investigational Site Number: 400 | Recruiting | Seattle | Washington | 98109 | United States |
| Investigational Site Number: 100 | Recruiting | Melbourne | 3000 | Australia |
| Investigational Site Number: 101 | Recruiting | Sydney | 2010 | Australia |
| Investigational Site Number: 251 | Withdrawn | Barcelona | 08023 | Spain |
| Investigational Site Number: 250 | Recruiting | Barcelona | 08035 | Spain |
| Investigational Site Number: 254 | Recruiting | Madrid | 28027 | Spain |
| Investigational Site Number: 252 | Recruiting | Madrid | 28223 | Spain |
| Investigational Site Number: 253 | Recruiting | Pamplona | 31008 | Spain |
| Investigational Site Number: 300 | Recruiting | London | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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