Phase 2 WSD0922-FU EGFR/EGFRvIII inhibitor plus adjuvant temozolomide in EGFR-mutant glioblastoma.

This randomized Phase 2 Mayo Clinic study tests whether adding WSD0922-FU—an oral, CNS-penetrant small-molecule inhibitor of EGFR and EGFRvIII—improves outcomes when combined with adjuvant temozolomide (an alkylating agent that damages tumor DNA) versus temozolomide alone in EGFR-mutant, IDH-wildtype glioblastoma after prior radiation + temozolomide. Patients are assigned to combination therapy or control, with MRI-based disease assessments and planned tissue/blood (optional CSF) collections to link target biology with response and resistance. A practical “bridge” is built in: at recurrence, participants heading to resection/biopsy can receive WSD0922-FU until surgery to support on-treatment sampling. The commercial/scientific angle is a brain-penetrant EGFR program (also developed with Wayshine Biopharm) moving into a controlled adjuvant setting where EGFR-targeted drugs have historically struggled due to BBB exposure and pathway heterogeneity. Today, patients typically receive maximal safe resection when feasible followed by radiation with temozolomide and then adjuvant temozolomide, with tumor-treating fields commonly considered; effective targeted options for EGFR-altered GBM remain limited, so this trial asks whether sustained EGFR pathway suppression can delay progression beyond temozolomide alone.