ALX2004 is an investigational EGFR-targeted antibody-drug conjugate being developed by ALX Oncology for EGFR-expressing solid tumors. It is the company's first internally developed ADC and uses a proprietary linker-payload platform with topoisomerase I payload design features intended to improve therapeutic window. FDA cleared its IND in April 2025 and Phase 1 development was planned for mid-2025.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
ALX Oncology reported fourth quarter and full year 2025 financial results, highlighting validation of CD47 as a predictive biomarker for evorpacept in HER2-positive cancers and progress in its ALX2004 EGFR-targeted ADC program.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07085091 |
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors |
RECRUITING | PHASE1 |
