NCT05167409

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Microsatellite Stable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Evorpacept (ALX148)	IV QW
DRUG	Cetuximab	IV QW
DRUG	Pembrolizumab	IV Q3W

Timeline

• Start date: 2022-07-28
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2021-12-22
• Last updated: 2025-01-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study