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eligibility_summary
Eligibility: Locally advanced/metastatic colorectal cancer after/intolerant to standard drugs (fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF, and anti-EGFR if RAS/BRAF wt). Prior trifluridine/tipiracil, regorafenib or fruquintinib allowed. MSI-H must have had an immune checkpoint inhibitor. ECOG ≤1, adequate organ function. Exclude: other cancers <3y (some exceptions), untreated/unstable brain mets, diarrhea/ileus >G1, stroke <6m. Other criteria apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: M9140 (precemtabart tocentecan), an antibody-drug conjugate (ADC) against CEACAM5 (CEA). Mechanism: A humanized anti-CEACAM5 monoclonal antibody binds CEACAM5 on tumor cells, is internalized, and releases a cytotoxic payload, the payload is a camptothecin-class topoisomerase I inhibitor (tocentecan), causing DNA damage and tumor cell death. Targets: CEACAM5-expressing colorectal cancer cells (tumor epithelium). Pathways impacted: CEACAM5 cell-adhesion antigen-mediated internalization, DNA replication/repair and cell-cycle progression via topoisomerase I inhibition leading to apoptosis. Phase 1, Q3W dosing with dose escalation.