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VIR-5525 · 1 trial · 3 indications
Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts. Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1: VIR-5525 Monotherapy Dose Escalation | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 2: VIR-5525 Monotherapy Dose Expansion | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 3: VIR-5525 Combination Dose Escalation | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
| Part 4: VIR-5525 Combination Dose Expansion | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| VIR-5525 | DRUG | Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion |
| Pembrolizumab | DRUG | Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion |
Inclusion Criteria: I 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \>18 years, at the time of signing the ICF. I 02. Have an ECOG performance status of 0 to 1. I 03. Have a life expectancy of at least 12 weeks. I 04. Have histological, pathologic...
VIR-5525 is an investigational small molecule being developed for the treatment of solid tumor malignancies, specifically EGFR positive solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.
VIR-5525 targets EGFR, a protein involved in cell growth and survival that is often overexpressed in certain solid tumors. By targeting EGFR, VIR-5525 aims to interfere with tumor growth pathways in EGFR positive malignancies.
VIR-5525 is being developed by Vir Biotechnology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIR. The company is conducting clinical trials to evaluate the safety and efficacy of VIR-5525 in patients with advanced solid tumors.
VIR-5525 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess its safety and preliminary efficacy.
VIR-5525 is being studied in a Phase 1 clinical trial with the identifier NCT06960395. This trial evaluates VIR-5525 alone and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study is recruiting up to 450 participants in the United States and Australia.
No, VIR-5525 is not the same as pembrolizumab. VIR-5525 is a small molecule targeting EGFR, while pembrolizumab is an immunotherapy that targets PD-1. In the ongoing clinical trial, VIR-5525 is being tested both alone and in combination with pembrolizumab.