eligibility_summary
Inclusion: Adults 18–75 with advanced/metastatic GI cancers (esophageal/gastric/colorectal), ECOG 0–1, RECIST-measurable disease, survival ≥3 mo, adequate organs/coagulation, LVEF ≥50%, tumor tissue available, prior toxicities ≤G1, no recent transfusion/growth factors, negative pregnancy/contraception. Exclusion: recent anti-cancer/immuno/steroid therapy, prior topo‑I ADC (BL‑B01D1), severe cardiac/QT/autoimmune/pulmonary/CNS mets, uncontrolled HTN/DM, other malignancy <5y, active infections (HIV/TB/HBV/HCV), unstable thrombosis/effusions, live vaccine/other trial <4w, allergy, prior transplant, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, recruiting in China, testing three regimens in advanced/metastatic GI tumors: SI-B003 monotherapy, BL-B01D1+SI-B003, and BL-B01D1+anti–PD-1, all IV every 3 weeks. Drugs/mechanisms: • BL-B01D1 (izalontamab brengitecan, BMS-986507) is an antibody–drug conjugate targeting TROP2 on epithelial tumor cells, upon internalization it releases a DNA topoisomerase I inhibitor payload, causing DNA damage and tumor cell death (with potential bystander effect). • PD-1 monoclonal antibody is an immune checkpoint inhibitor that blocks PD-1 on T cells to restore antitumor activity. • SI-B003 is an investigational immunotherapy biologic, the specific target/mechanism is not specified in the listing. Targets/pathways: TROP2-positive tumor cells, DNA topoisomerase I–mediated cytotoxicity, PD-1/PD-L1 axis on effector T cells. Combos aim to couple ADC-driven tumor killing with immune activation.