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

Adult
- Histologically confirmed unresectable metastatic colorectal adenocarcinoma (all primary tumor locations are allowed). - If in Cohort A, the patient must state willingness to undergo pre- and post-treatment biopsies. - 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). - Patients with known MSI-high status or known mismatch repair deficiency (dMMR) are excluded. - Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137) not permitted. - Prior treatment with any anti-CD47 or anti-SIRPα drugs not permited. - Known active CNS metastases and/or carcinomatous meningitis not permitted.
Treatment
Rutgers Cancer Institute of New Jersey
Swedish Cancer Center
University of Arizona Cancer Center
University of Colorado Hospital
University of Kansas Cancer Center

Robert Lentz, MD
Protocol Number: 22-0110
More information available at ClinicalTrials.gov: NCT05167409
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