eligibility_summary
Inclusion: 18–75, HER2+ gastric/GEJ adenocarcinoma, measurable disease, ECOG 0–1, survival ≥3 mo, adequate organs (LVEF ≥50%, proteinuria ≤2+/≤1000 mg/24 h), contraception, negative pregnancy test. Exclusion: recent therapy or camptothecin‑ADC, major cardiac/cerebrovascular/arrhythmic, lung/ILD, uncontrolled HTN, CNS mets, active infection, autoimmune disease, HBV/HCV/HIV, steroids/immunosuppression, other cancer <5 y, transplant, severe neuro/psych illness, allergy, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: BL-M07D1 plus a PD-1 monoclonal antibody (listed MeSH: spartalizumab). Drug types and mechanisms: • BL-M07D1: a HER2-targeted antibody–drug conjugate (anti-HER2 mAb linked to a cytotoxic payload, consistent with topoisomerase I/camptothecin-class payloads). It binds HER2 on tumor cells, is internalized, releases the payload to cause DNA damage and tumor cell death, Fc-mediated ADCC may also contribute. • PD-1 monoclonal antibody (immune checkpoint inhibitor): blocks PD-1 on T cells to restore antitumor T-cell activation and cytotoxicity. Targets/cells/pathways: • HER2 receptor on gastric/GEJ adenocarcinoma cells (tumor cell surface). • PD-1/PD-L1 immune checkpoint pathway on T lymphocytes and tumor/immune cells in the tumor microenvironment, enhancing CD8+ T-cell–mediated killing.