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

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05167409

Patient View

This Phase 2 open-label trial assesses evorpacept, cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer after two therapy lines. It includes a safety run-in and dose expansion. Eligibility requires adequate organ function. Evorpacept and cetuximab are administered weekly, while pembrolizumab is given every three weeks.

Patient Parameters

Program Overview

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

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.

Eligibility 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)

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