eligibility_summary
Adults (≥18) with progressing mCRC after FOLFOX/FOLFIRI/FOLFOXIRI/TAS‑102/regorafenib ± anti‑VEGFR, anti‑EGFR if RAS‑WT left, MSI‑H/dMMR after CPI+≥2 lines, BRAF V600E after cetuximab+encorafenib. Measurable disease, ECOG ≤2, contraception/neg pregnancy test, adequate organ function. Exclude: recent cancer/trial/tx/surgery, ≥G2 tox/infection, CNS mets, HIV/HBV/HCV, autoimmune, anticoagulation, NYHA III/IV, severe lung disease, CC‑3 intolerance, live vaccine, pregnancy/lactation, ileus.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05999396 (Phase I, FIH) testing CC-3 in heavily pretreated metastatic colorectal cancer. Intervention: CC-3, a bispecific T‑cell–engaging antibody (IgG-based bsAb) that binds CD276 (B7‑H3) and CD3. Mechanism: CC-3 bridges T cells to CD276+ targets, activating TCR/CD3 signaling to induce cytotoxic killing, its “dual targeting” also binds CD276 on tumor vasculature, potentially disrupting tumor blood supply and enhancing immune cell infiltration. Format features: attenuated CD3 binder to limit off‑target T‑cell activation/CRS, YTE Fc modification to prolong half‑life (enhanced FcRn binding), enabling effective weekly dosing. Targets/cells/pathways: CD276 on CRC tumor cells and tumor endothelial cells, CD3 on CD4+/CD8+ T cells, TCR signaling, immune synapse formation, cytolysis, vascular targeting/anti‑angiogenic effects. Design: open‑label dose escalation/expansion to define MTD/RP2D with PK/PD and preliminary efficacy.