eligibility_summary
Adults ≥20 with unresectable/metastatic biliary tract cancer (incl. cholangiocarcinoma, gallbladder), untreated or recurrence >6 mo, Globo H H-score ≥80, 3±1 mo GemCis with SD/PR/CR and plan to continue, measurable disease, ECOG 0–1, life ≥6 mo, adequate organs. Exclude CNS mets, pregnancy, splenectomy, active HIV/HBV/HCV (controlled HBV/inactive HCV ok), autoimmune on immunosuppression, unresolved >G1 AEs, uncontrolled illness, severe drug allergy, or recent anticancer/immune tx (<4 wks).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06490198: Single-arm Phase 2 maintenance in advanced Globo H–positive biliary tract cancer. Intervention: OBI-833/OBI-821, a therapeutic cancer vaccine. OBI-833 is a glycoconjugate linking the tumor-associated carbohydrate antigen Globo H to CRM197 (inactive diphtheria toxin carrier), OBI-821 is a purified saponin adjuvant (QS-21–like) from Quillaja. Mechanism: enhances antigen presentation and T-helper priming to induce strong anti–Globo H humoral (and cellular) immunity, promoting immune-mediated killing of Globo H–expressing tumor cells. Administered SC while patients continue gemcitabine (antimetabolite) and cisplatin (DNA crosslinker). Targets: Globo H on epithelial tumor cells, engages APCs, B cells/antibody effector pathways, and T-cell responses.