eligibility_summary
Eligibility: ECOG 0-1, HER2+ (IHC >=2+ within 6 mo) advanced/metastatic breast or gastric/GEJ, refractory/intolerant or no standard tx, prior therapy: breast >=2 lines, gastric/GEJ >=1, IHC3+ or 2+/ISH+ need prior HER2 therapy. Exclude: other malignancy, significant cardiac disease, active CNS mets unless >=3 mo remission, unresolved AEs, uncontrolled infection, cyclophosphamide/fludarabine intolerance, pregnancy/lactation or no contraception thru 6 mo post-dose, rapid decline <=2 wks pre-lymphodepletion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05678205 (withdrawn) planned a Phase 1/2, open-label study in advanced HER2+ breast and gastric/GEJ cancers. Interventions: AB-201, an adoptive natural killer (NK) cell therapy intended to eliminate HER2-expressing tumor cells via NK-mediated cytotoxicity, plus lymphodepleting chemotherapy with cyclophosphamide (alkylating agent) and fludarabine (purine analog) to enhance NK-cell engraftment/expansion. Targets/pathways: HER2 on tumor cells, NK effector pathways (perforin/granzyme-driven apoptosis) against HER2+ cells, lymphodepletion targets host lymphocytes to reduce immune rejection and improve persistence of infused NK cells.