Status:
NOT_YET_RECRUITING
Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Cholangiocarcinoma
Chemotherapy Effect
Eligibility:
All Genders
20-99 years
Phase:
PHASE1
Brief 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 wi...
Detailed Description
This clinical trial is a single-arm, phase 2 study evaluating OBI-833/OBI-821 as maintenance therapy in patients with Globo H-positive advanced biliary tract cancer who have not progressed on first-li...
Eligibility Criteria
Inclusion
- Aged ≥ 20 years.
- Histologically confirmed, unresectable advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patient with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
- Patient must have a documented Globo H H-score of at least 80 using a validated central IHC assay.
- Patient must have received 3±1 months of the first-line GemCis regimen (gemcitabine, 1000 mg/m2 and cisplatin, 25 mg/m2 on days 1 and 8 of each 21-day cycle), have achieved SD, PR, or CR before enrollment (as confirmed by the Investigator), and plan to continue the GemCis regimen.
- At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
- Life expectancy ≥ 6 months.
- East 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); AST/ALT ≤ 5X ULN in the presence of liver metastases Total bilirubin ≤ 2.0 X ULN Serum creatinine ≤ 1.5X ULN ANC ≥ 1,5500 /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.
- Understand and provide a written informed consent document according to institutional guidelines.
Exclusion
- Patient who has CNS metastasis or spinal cord compression.
- Patient who is pregnant or breast-feeding at entry.
- Patient with splenectomy.
- Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection. Patients with hepatitis B infection under anti-HBV medications are exceptionalcan be included in the study. Patients with hepatitis C infection history but inactive status are exceptionalcan be included in the study.
- Patient 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).
- 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.
- A history of other malignancies (except non-melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer) within 5 years.
- Patient 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.
- Treatment with any of the following therapies within 4 weeks prior to the first dose of OBI-833/OBI-821:
- Anti-cancer therapies, including chemotherapy and targeted therapy (except the GemCis regimen).
- Radiotherapy.
- 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.
- Patient 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 to be unsuitable for the study.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06490198
Start Date
July 31 2024
End Date
July 31 2027
Last Update
July 8 2024
Active Locations (2)
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1
Chang Gung Memorial Hospital Linkou Branch
Taoyuan District, Taiwan, 333
2
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan District, Taiwan