eligibility_summary
Inclusion: Adults 18–75 with epithelial solid tumors (advanced gastric/colorectal after ≥2 failed lines or platinum‑resistant ovarian) and moderate+ malignant ascites, IP washout ≥2 wks, no systemic washout, prior AEs ≤G1, ECOG 0–2, survival ≥8 wks, adequate organ function, contraception. Exclusion: allergy to study drug/antibodies, EpCAM/CD3 use ≤4 mo, CNS mets with symptoms, major surgery <4 wks, recent infection, severe pulmonary, autoimmune (exceptions), CV/TE, GI obstruction/perforation, undrainable/chylous ascites, portal HTN/embolism, active HBV/HCV/HIV/syphilis, symptomatic pleural/pericardial effusion, pregnancy, serious neuro/psychiatric.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: M701, an intraperitoneal recombinant human–mouse chimeric bispecific T‑cell–engaging antibody (anti‑EpCAM × anti‑CD3). Mechanism: binds EpCAM on epithelial tumor cells and CD3 on T cells to form an immune synapse, activate TCR/CD3 signaling, and redirect cytotoxic T‑cell killing (perforin/granzyme, cytokine release) against EpCAM+ tumor cells, aiming to control peritoneal tumor burden and fluid production. Comparator: paracentesis alone (mechanical ascites drainage). Cells/targets: EpCAM‑expressing epithelial cancer cells (e.g., gastric, colorectal, ovarian) and CD3+ T lymphocytes in the peritoneal cavity. Pathways: T‑cell activation and effector cytotoxicity with local immune modulation of the peritoneal microenvironment.