Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIR-5500 · 1 trial · 1 indication
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)
Incidence and severity of AEs 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 |
| Androgen receptor signaling inhibitor (ARSI) | DRUG | 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) ...
VIR-5500 is an investigational small molecule being developed for the treatment of hormone-refractory prostate cancer. It is currently in Phase 1 clinical development. The drug is being studied in a clinical trial that evaluates its safety, pharmacokinetics, and preliminary efficacy in patients with this condition.
VIR-5500 targets PSMA, which is an antigen. PSMA is a well-known cell surface protein that is highly expressed in prostate cancer cells. By targeting PSMA, VIR-5500 is designed to interact with cancer cells that express this antigen, potentially offering a therapeutic approach for hormone-refractory prostate cancer.
VIR-5500 is being developed by Vir Biotechnology, Inc., a company publicly traded under the ticker symbol VIR. The company is conducting clinical research on this drug candidate for the treatment of hormone-refractory prostate cancer.
VIR-5500 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to assess the drug's safety, pharmacokinetics, and preliminary efficacy in patients with hormone-refractory prostate cancer.
VIR-5500 is being studied in a Phase 1 clinical trial with the identifier NCT05997615. This trial is titled 'Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer' and is currently recruiting participants. The trial is enrolling male patients aged 18 years and older with hormone-refractory prostate cancer.
Yes, VIR-5500 is also known as AMX-500. The clinical trial NCT05997615, which is evaluating VIR-5500, is titled 'Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer,' confirming that both names refer to the same investigational drug.