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Also known as AMX-525
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 developed by Vir Biotechnology, Inc. for the treatment of locally advanced or metastatic solid tumor malignancies, including EGFR positive solid tumors. It is being studied both as a single agent and in combination with pembrolizumab in a Phase 1 clinical trial.
VIR-5525 is being evaluated for locally advanced or metastatic solid tumors, with enrollment focused on EGFR positive solid tumors. It is an investigational therapy and has not been approved for any indication. The Phase 1 study is designed to assess safety and preliminary efficacy.
VIR-5525 targets EGFR, a protein that is commonly altered in solid tumors. By acting on this molecular target, the small molecule is designed to interfere with EGFR-driven tumor biology. The Phase 1 trial enrolls participants with EGFR positive solid tumors, reflecting the biomarker-selected design.
VIR-5525 is being developed by Vir Biotechnology, Inc., which trades on the Nasdaq under the ticker VIR. The company is the sponsor of the ongoing Phase 1 clinical program evaluating the compound in solid tumor malignancies, both as monotherapy and in combination with pembrolizumab.
VIR-5525 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The single ongoing trial is currently recruiting participants in the United States and Australia.
VIR-5525 is being studied in the Phase 1 trial NCT06960395, titled Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors. The trial is recruiting, plans to enroll 450 participants aged 18 years and older, and is conducted in the United States and Australia.