Study on Evorpacept (ALX148) with Cetuximab and Pembrolizumab for Hard-to-Treat Metastatic Colorectal Cancer

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05167409

Provider View

This Phase 2 clinical trial is testing a new combination of drugs, including evorpacept (ALX148), cetuximab, and pembrolizumab, to see if they can help treat metastatic colorectal cancer that hasn't responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if a combination of three drugs—evorpacept (ALX148), cetuximab, and pembrolizumab—can be effective for patients with metastatic colorectal cancer that is microsatellite stable and has not improved with at least two prior treatments. The trial will start with a safety phase to ensure the treatment is safe, followed by a phase where more patients will receive the treatment to see how well it works. Some patients will also have biopsies as part of the study. Participants will continue the treatment until their cancer progresses.

Description

This clinical trial is open-label, meaning both the researchers and participants know what treatment is being given. It is conducted at multiple centers and involves a single group of patients. The trial is in Phase II, which means it is focused on assessing the effectiveness and safety of the treatment. The study includes a safety run-in phase to monitor any side effects before expanding to include more patients. Participants will receive a combination of evorpacept (ALX148), cetuximab, and pembrolizumab. The treatment will continue until the cancer shows signs of progression, as measured by standard criteria. Some patients will also undergo biopsies to help researchers understand how the treatment affects the cancer.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic colorectal cancer that has been treated with at least two different therapies for cancer that cannot be surgically removed or has spread.
  • Have microsatellite stable cancer, which means the cancer does not have a specific type of genetic instability.
  • Have good blood and organ function as determined by medical tests.

Exclusion Criteria

  • Have a type of colorectal cancer known as MSI-high or have a mismatch repair deficiency.
  • Do not know the mismatch repair or microsatellite stability status of the cancer.
  • Have had severe allergic reactions to any of the study drugs or similar drugs.
  • Have a specific type of colorectal cancer that is RAS/BRAF wild-type and have not been treated with EGFR inhibitors.
  • Have previously been treated with drugs targeting PD-1, PD-L1, PD-L2, CD47, SIRPα, or other similar immune system targets.

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