A phase II study (with safety run-in) of ALX148 in combination with cetuximab and pembrolizumab in patients with refractory microsatellite stable metastatic colorectal cancer
- 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.
University of Colorado Hospital
Wells Messersmith, MD
Protocol Number: 22-0110
More information available at ClinicalTrials.gov: NCT05167409
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