Vir Biotechnology, Inc.
This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR. The study will be conducted in the following 4 parts: * Part 1: VIR-5525 monotherapy dose escalation * Part 2: VIR-5525 monotherapy dose expansion * Part 3: VIR-5525 plus pembrolizumab dose escalation * Part 4: VIR-5525 plus pembrolizumab dose expansion
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, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic. I 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has be…
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion