Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
CholangiocarcinomaChemotherapy EffectImmunotherapy
Interventions
DRUG

OBI-833/OBI-821

"OBI-833 is a glycoconjugate that consists of Globo H, a unique tumor-associated carbohydrate antigen (TACA), covalently linked to cross-reacting material 197 (CRM197), an inactive and nontoxic form of diphtheria toxin (DT) acting as the carrier protein.~OBI-821 is a saponin-based adjuvant derived from the bark of the Quillaja saponaria Molina tree. It is a purified saponin adjuvant structurally similar to adjuvant QS-21. The OBI-833/OBI-821 combination represents a carbohydrate-conjugate vaccine combined with an immune adjuvant, intended to serve as an active cancer immunotherapy."

Trial Locations (2)

333

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

Unknown

Chang-Gung Memorial Hospital, Linkou Branch, Taoyuan District

All Listed Sponsors
lead

Chang Gung Memorial Hospital

OTHER

NCT06490198 - Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin | Biotech Hunter | Biotech Hunter