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Brief Title: A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer
Official Title: A Phase II Study (With Safety run-in) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab in Patients With Refractory Microsatellite Stable Metastatic Colorectal Cancer
Study ID: NCT05167409
Brief Summary: This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer
Detailed Description: This is an open-label, multi-center, single-arm phase II clinical trial (with safety run-in) evaluating the combination of evorpacept (ALX148), cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer who have progressed on at least 2 lines of systemic therapy. A subset of patients will undergo study-related biopsies. There will be a safety run-in stage followed by a dose expansion stage. Patients in both stages will continue to receive study therapy until disease progression according to RECIST v1.1.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rutgers Cancer insititute, New Brunswick, New Jersey, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Name: Robert Lentz, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR