To Evaluate OBI-833/OBI-821 in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer for Recurrence

NCT05376423 | Unknown Phase 2

• 1 other identifier: 202106018MIPB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 2 Study to Evaluate Adjuvant OBI-833/OBI-821 Therapy in Patients With Locally Advanced, Globo H-Positive Esophageal Cancer at High Risk for Recurrence

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival rate

  To evaluate the effect of OBI-833/OBI-821 treatment on improving recurrence-free survival in patients with locally advanced, Globo H-positive esophageal cancer in the adjuvant setting

  one year

Study Arms (2)

OBI-833/OBI-821

EXPERIMENTAL

OBI-833 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 a carrier protein. OBI-821 is a purified saponin adjuvant Dosage form: solution Dosage:30 μg OBI-833/100 μg OBI-821, subcutaneous injection, Frequency: weekly for 4 doses (weeks 1, 2, 3, 4), then every 2 weeks for 2 doses (weeks 6, 8), then every 4 weeks for 4 doses (weeks 12, 16, 20, 24), and then every 8 weeks until disease recurrence, intolerable adverse events/toxicity, consent withdrawal, death, or up to 80 weeks from randomization.

Biological: OBI-833/OBI-821

Observation

NO INTERVENTION

Patients will be randomized into OBI-833/OBI-821 (experimental) arm or observation arm.

Interventions

OBI-833/OBI-821 BIOLOGICAL

OBI-833 and OBI-821 are individually formulated into separate glass vials. The articles are mixed prior to subcutaneous administration at the clinic.

OBI-833/OBI-821

Eligibility Criteria

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

You may qualify if:

• Male or female patients, 20 years of age or older at the time of consent.
• Pathologically or cytologically confirmed diagnosis of esophageal cancer (including squamous cell carcinoma and adenocarcinoma) whose postneoadjuvant pathologic stage is ypT1-4 AND ypN1-3 according to the AJCC Cancer Staging System, 8th Edition.
• Patients have been treated with preoperative cisplatin-based chemoradiotherapy followed by esophagectomy with lymph node dissection for locally advanced esophageal cancer (defined by the above criterion).
• Postneoadjuvant pathologic staging: ypT1-4 and ypN1-3.
• Globo H IHC H-score ≥1 in the surgical tumor specimen from the primary site/or lymph node (if the primary site is not available). The Globo H expression will be determined by a qualified laboratory.
• R0 (no residual tumor on the surgical margin of the resected tumor specimen).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Organ Function Requirements - Subjects must have adequate organ functions as defined below:
• AST/ALT ≤ 3X ULN (upper limit of normal)
• Total bilirubin ≤ 2X ULN
• Serum creatinine ≤ 1.5X ULN
• ANC ≧ 1,500 /μL
• Platelets ≧ 100,000/μL
• All eligible patients of childbearing potential must use effective contraception during study treatment and for at least 2 months after the last dose of OBI-833/OBI-821. Subjects not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
• Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.

You may not qualify if:

• Subjects who cannot be randomized within 8 weeks after the esophageal cancer surgery.
• Subjects who are pregnant or breast-feeding at entry.
• Subjects with splenectomy.
• Has prior malignancy, except (a) adequately treated basal cell or squamous cell skin cancer; (b) in situ cervical cancer; (c) previously diagnosed malignancy which has been adequately treated and shown no evidence of recurrence for more than 5 years.
• Subjects with HIV infection, active hepatitis B infection, or active hepatitis C infection.
• Subjects with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
• \- e.g., type 1 juvenile-onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graves disease, Hashimoto thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, Crohn disease, ulcerative colitis, and psoriasis.
• Subjects with any known uncontrolled comorbid illness, including ongoing or active infections, symptomatic congestive heart failure (NYHA\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects who have received any of the following medications within 4 weeks prior to randomization:
• Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors.
• Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide.
• Other biologics, including G-CSF and other hematopoietic growth factors.
• Live attenuated vaccines.
• IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. Use of inhaled and topical (except on the injection site) steroids is allowed.
• Alternative and complementary medicine that may affect the immune system.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jang-Ming Lee

  Department of Surgery, National Taiwan University Hospital. Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jang-Ming Lee

CONTACT

+886-2-23123456; jangminglee@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: June 2, 2022
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

TW (1)