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

Stopped early · Phase 2

Conditions studied: Microsatellite Stable Metastatic Colorectal Cancer

In brief

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

Key facts

Study ID: NCT05167409
Run by: University of Colorado, Denver
People needed: 19
Starts: 2022-07-28
Expected to finish: 2024-10-30
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be eligible to participate in this study, an individual must meet all of the following criteria at screening (any assessments included in the Schedule of Events [Section 1.3] on Cycle 1 Day 1 must also continue to be met for the patient to remain eligible):
Provision to sign and date the consent form.
Able to comply with all study procedures and be available for the duration of the study in the Investigator's judgment.
Age ≥ 18 years on the day of signing informed consent
If in Cohort A, the patient must state willingness to undergo pre- and post-treatment biopsies. According to the Investigator's judgement, the planned biopsies should not expose the patient to substantially increased risk of complications.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically confirmed unresectable metastatic colorectal adenocarcinoma.
All primary tumor locations are allowed
Measurement of EGFR expression by immunohistochemistry is not required
Progression on at least two prior lines of therapy for unresectable metastatic colorectal adenocarcinoma.
A patient who progressed on a single line of therapy including a fluoropyrimidine, oxaliplatin, and irinotecan for unresectable metastatic colorectal adenocarcinoma (e.g., FOLFIRINOX or FOLFOXIRI) is eligible.
Previous administration of anti-EGFR drugs does not impact eligibility, except as listed in Exclusion Criterion #15.
Microsatellite stable or proficient mismatch repair status documented (only one of these criteria is needed, however if one criterion is met and one is not met then the patient is excluded)
Measurable disease, according to RECIST v1.1. Previously irradiated lesions are not considered measurable unless progression has been documented in the lesion. Note that lesions intended to be biopsied should not be target lesions.
Adequate hematologic and end organ function, defined by the following laboratory results:
ANC ≥ 1.5 × 109/L
Platelet count ≥ 100 × 109/L
Hemoglobin ≥ 9 g/dL without transfusion in the previous week
Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN); patients with known Gilbert's disease may have a bilirubin ≤ 3.0 ×ULN
AST, ALT, and alkaline phosphatase (ALP) ≤ 3 × ULN with the following exceptions:
Patients with documented liver metastases: AST and/or ALT ≤ 5 ×ULN
Patients with documented liver or bone metastases: ALP ≤ 5×ULN
Creatinine clearance ≥ 50 mL/min as calculated using the Cockcroft-Gault formula or measured using a 24-hour urine collection
International normalized ratio (INR) OR prothrombin time (PT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as INR or PT is within expected or therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as aPTT is within expected or therapeutic range of intended use of anticoagulants

Where it is running

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

Full record on ClinicalTrials.gov

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