NCT05376423RecruitingPhase 2
A Randomized, Open-Label, 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
National Taiwan University Hospital1 site in 1 country60 target enrollmentStarted: June 2, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Recurrence-free survival rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •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
- •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-
- •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.
Exclusion Criteria
- •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.
- •Other investigational drugs
- •Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
- •Subjects with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.
- •Any other reason that the investigator deems the patient as unsuitable for the study.
Arms & Interventions
Observation
No Intervention
Patients will be randomized into OBI-833/OBI-821 (experimental) arm or observation arm.
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.
Intervention: OBI-833/OBI-821 (Biological)
Outcomes
Primary Outcomes
Recurrence-free survival rate
Time Frame: one year
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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