eligibility_summary
Eligibility: HER2-positive by IHC/ISH/NGS, ECOG 0–1, LVEF ≥50% (ECHO/MUGA), adequate organ/marrow function. Exclude: prior anti-CD47/SIRPα, recent (<28 d) surgery, radiotherapy, immunostimulatory, investigational or other anticancer therapy, recent (<14 d) immunosuppressives, uncontrolled illness, unresolved ≥Grade 2 toxicities (except vitiligo/alopecia), or investigator deems noncompliant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05957536. Intervention: D3L-001, an intravenous biological immunotherapy (first-in-human, monotherapy dose-escalation/expansion). Mechanism of action: Not explicitly disclosed in the registry. The exclusion of prior anti-CD47 or SIRPα agents suggests D3L-001 engages the CD47–SIRPα innate immune checkpoint (likely an antibody or fusion protein), aiming to lift the “don’t-eat-me” signal and enhance macrophage-mediated phagocytosis and antitumor immunity, potentially focused on HER2+ cells. Targets: HER2-positive tumor cells (breast, gastric/GEJ) and the CD47–SIRPα pathway on tumor and myeloid cells (macrophages).