Brief Summary
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 dosethe amount of medication taken escalation
- Part 2: VIR-5525 monotherapy dose expansion
- Part 3: VIR-5525 plus pembrolizumab dose escalation
- Part 4: VIR-5525 plus pembrolizumab dose expansion
Intervention / Treatment
- Drug: VIR-5525
- Drug: Pembrolizumab
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 advancedat a late stage, far along, 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 been demonstrated in such lesions.
- I 06. Have diseases under study, lines of therapy, and biomarker status, as follows:
- Have one of the following:
- (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC. Note: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.
OR
-
- Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).
- Have no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.