Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05997615 | Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer | PHASE1 | RECRUITING | 437 | — | — | Aug 10, 2023 | Sep 29, 2027 | Jun 4, 2026 | 12 | United States, Australia +2 |
Incidence and severity of AEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Incidence and nature of DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| VIR-5500 | DRUG | Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion |
| ARSI | COMBINATION_PRODUCT | Oral administration |
Inclusion Criteria: Applicable to Parts 1 and 2 1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging 2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) ...