Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype

NCT03608878 | Terminated Phase 2

• 1 other identifier: CGMH/TMUH/VGH-OBI822-HCC001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

TACE against HCC is the standard of care for BCLC stage B patients. In this exploratory study, the investigators assess the efficacy of TACE with or without adagloxad simolenin/OBI-821 treatment in GALNT14 "non-TT" HCC population.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• time-to-ITTVP

  time-to-intrahepatic total tumor volume progression

  From enrollment till 36 months of follow-up.

Study Arms (2)

TACE alone arm

ACTIVE COMPARATOR

TACE (Transarterial Chemoembolization)

Procedure: TACE

adagloxad simolenin arm

EXPERIMENTAL

TACE plus adagloxad simolenin/OBI-821 adjuvant therapy

Biological: adagloxad simolenin/OBI-821; Procedure: TACE

Interventions

adagloxad simolenin/OBI-821 BIOLOGICAL

Adagloxad simolenin (OBI-822) is a glyco-conjugated protein comprised of a carbohydrate tumor antigen. Globo H allyl glycoside is covalently linked to a carrier protein KLH, presented in a dominant trimer form with molecular weight between 1200-1395 kDa., to form Adagloxad simolenin (OBI-822) (Globo H-KLH) OBI-821 is a saponin based adjuvant structurally similar to descriptions found in the literature for another adjuvant, QS-21. Adagloxad simolenin will be mixed with OBI-821 before administration.

adagloxad simolenin arm

TACE PROCEDURE

Transarterial chemoembolization

TACE alone arm; adagloxad simolenin arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Diagnosis of HCC
• Has a Globo-H or SSEA-3 positive tumor as determined by IHC
• Never received TACE/ chemotherapy/ radiotherapy or targeted agents prior to this study.
• Patients should be in BCLC clinical stage B (multinodular asymptomatic tumors without extra-hepatic spread or portal vein invasion) with or without unilateral secondary or tertiary branches of portal vein invasion.
• Child-Pugh functional class A or B.
• GALNT14- rs9679162 "non TT" genotype
• At least 1 measurable lesion must be present.
• ECOG performance status 0 to 1.
• Age \> 20 years
• Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial and 4 weeks after last treatment
• Informed consent must be obtained prior to perform any study procedure.
• Total bilirubin \< 3.0 mg/dL with no evidence of biliary tract obstruction.
• Appropriate Serum alanine aminotransferase, aspartate aminotransferase, Absolute neutrophil count, Platelets and Serum creatinine
• (16) Antiviral treatment for hepatitis B or C is allowed except for interferon.

You may not qualify if:

• BCLC stage A.
• Presence of extrahepatic metastasis or main portal vein thrombosis.
• Child-Pugh score = C.
• Significant cardiac disease as determined by investigator.
• Serious bacterial infection requiring systemic antibiotics.
• Pregnancy
• Expected non-compliance.
• Uncontrolled illness including, but not limited to, ongoing infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
• Bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
• Subjects with known HIV infection.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Chau-Ting Yeh, MD

  LinKou Chang Gung Menorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Liver Research Center; Professor

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 1, 2018
• Study Start: April 26, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)