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

NCT06490198 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-08

No results posted yet for this study

Summary

A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833/OBI-821, a carbohydrate-conjugate vaccine combined with an immune adjuvant, as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer. The study is designed as a single-arm trial with 30 patients who have achieved stable disease, partial response, or complete response after 3±1 months of initial chemotherapy. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, tumor response, and safety profile. The treatment regimen involves subcutaneous injections of OBI-833/OBI-821 on a gradually decreasing frequency schedule for up to 80 weeks. The trial also includes exploratory objectives to assess immune responses and biomarkers. This study aims to address the unmet need for improved treatment options in advanced biliary tract cancer by leveraging the potential of immunotherapy targeting the Globo H antigen.

Conditions

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chun-Nan Yeh · Department of Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490198 on ClinicalTrials.gov