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

• Status: Not yet recruiting
• Trial end date: 2025-06-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Criterium, Inc.
• Collaborators: ALX Oncology Inc.; Eli Lilly and Company; Merck Sharp & Dohme Corp.
• Treatments: Cetuximab; Pembrolizumab

Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

• Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease

• Have microsatellite stable disease

• Adequate hematologic and end organ function

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Patients with known MSI-high status or known mismatch repair deficiency (dMMR)

• Patients in whom both mismatch repair and microsatellite stability status are unknown

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes

• Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.

• Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)