Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

Phase 2 Terminated 19 enrolled University of Colorado, Denver ALX Oncology Inc. · collab Academic GI Cancer Consortium (AGICC) · collab Criterium, Inc. · collab Eli Lilly and Company · collab Merck Sharp & Dohme LLC · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

Timeline

Start: 2022-07-28
Primary completion: 2024-10-30
Completion: 2024-10-30

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

Stopped (Enrollment): “Accrual was terminated due to safety concerns”

paper Among all patients, the objective response rate was 6.3%; formal hypothesis testing was not performed. PMID 41171165 ↗

Publications

Lentz RW, Lang J, Pitts TM, Blatchford P, Hu J, Jordan KR, Van Bokhoven A, Bagby SM, Dominguez ATA, Binns CA, Robinson HR, Balmaceda N, Baiyee E, Leal AD, Kim SS, Davis SL, Lieu CH, Wadlow RC, Spencer K, Scott AJ, Boland PM, Hochster HS, Messersmith WA. Phase II Clinical Trial and Preclinical Evaluation of a Novel CD47 Blockade Combination in Refractory Microsatellite-Stable Metastatic Colorectal Cancer. Cancer Res Commun. 2025 Nov 1;5(11):2039-2052. doi: 10.1158/2767-9764.CRC-25-0332.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Evorpacept	Protein / enzyme biologic	10 mg/kg	Intravenous
Subject	Evorpacept	Protein / enzyme biologic	15 mg/kg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous