eligibility_summary
Adults with unresectable metastatic colorectal adenocarcinoma, KRAS/NRAS/BRAF WT, ECOG 0–2, adequate counts/renal/hepatic function, measurable disease, consent/contraception, biopsy required. Cohort A: ≤1 prior chemo cycle, B: 1–2 prior lines, C: no prior metastatic therapy, resection candidates (≤1 cycle allowed). Exclude: ≥G2 toxicity (except neuropathy), other active cancer, prior anti‑EGFR (A,C), HER2+, recent major surgery, immunosuppression, brain mets, serious infection, major cardiac disease, uncontrolled HTN, myocarditis or arrhythmias, significant bleeding, pregnancy/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06011772 tests CIMAvax-EGF plus standard therapy in metastatic KRAS/NRAS/BRAF wild-type colorectal cancer. CIMAvax-EGF is a therapeutic vaccine (recombinant human EGF conjugated to a carrier with Montanide adjuvant) that elicits anti-EGF antibodies to deplete circulating EGF and dampen EGFR signaling on tumor cells. Combination backbones: FOLFOX or FOLFIRI with biologics. Mechanisms: 5-FU (antimetabolite, thymidylate synthase inhibition), leucovorin (enhances 5-FU), oxaliplatin (platinum DNA crosslinker), irinotecan (topoisomerase I inhibitor), bevacizumab (anti-VEGF-A, anti-angiogenesis), cetuximab/panitumumab (anti-EGFR mAbs). Targets/pathways: EGFR axis (ligand EGF and receptor on epithelial tumor cells, downstream MAPK/PI3K in RAS/BRAF WT tumors), VEGF/angiogenesis (endothelial cells), DNA synthesis/repair and Topo I in proliferating tumor cells, and humoral B-cell response to EGF.