Also known as: ALX148
Evorpacept is an investigational CD47-targeted immuno-oncology therapy developed by ALX Oncology. It is designed to block the tumor-cell 'don't eat me' signal and enhance innate immune recognition and anti-tumor responses, including in combination with other anti-cancer therapies. The program remains in clinical development and is not approved for routine use.
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.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
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 |
|---|---|---|---|
| NCT05787639 |
Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05524545 |
A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07) |
COMPLETED | PHASE1 |
| NCT05027139 |
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer |
COMPLETED | PHASE1/PHASE2 |
| NCT04755244 |
A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05) |
TERMINATED | PHASE1 |
| NCT04675333 |
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04675294 |
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04643002 |
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol |
RECRUITING | PHASE1/PHASE2 |
| NCT04417517 |
A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02) |
TERMINATED | PHASE1 |
