Status:
UNKNOWN
Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Oncolys BioPharma Inc
Collaborating Sponsors:
Medigen Biotechnology Corporation
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative phase I trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 18 patients will be r...
Detailed Description
After screening, each eligible patient will undergo a treatment of OBP-301 within 14 days and will automatically enter follow-up period. The follow-up period is up to 12 weeks after the last injectio...
Eligibility Criteria
Inclusion
- Patients aged 18 to 65 years (19 to 65 years in Korea), either sex
- Patients diagnosed with hepatocellular carcinoma. The diagnosis of HCC (hepatocellular carcinoma) should be established by cytology or histopathology
- Patients who have unresectable HCC and meet all of the following conditions:
- Barcelona Clinic Liver Cancer (BCLC) stage B or C
- TransAarterial ChemoEmbolization (TACE) refractory in discretion of the investigators, or TACE unsuitable (such as but not limited to portal vein thrombosis)
- Local ablative treatment (such as percutaneous ethanol injection, radiofrequency ablation, etc) unsuitable
- Sorafenib failure, intolerable or ineligible
- Patients must have at least one lesion that can be accurately measured in at least one dimension as 1 cm or more and the lesion must be suitable for repeat measurement
- Patients who have Child-Pugh's Score no greater than 7, and have no ascites
- Patients who have all the conditions below at screening:
- serum ALT (Alanine Aminotransferase) level (GPT) less than 2.5 x UNL
- serum AST (Aspartate Aminotransferase) level (GOT) less than 2.5 x UNL
- WBC (white blood cell) greater than or equal to 3,000 / microliter
- Serum creatinine less than or equal to 1.5 x UNL
- activated partial thromboplastin time (APTT) \<1.5 x UNL
- Platelet count correctable to greater than or equal to 80,000 / microliter
- prothrombin time-international normalized ratio (PT-INR) correctable to less than 1.5
- Patients who have life expectancy longer than 12 weeks
Exclusion
- Patients who have had chemotherapy within last three weeks (6 weeks for nitrosourea or Mitomycin-C) prior to dosing
- Patients who have had radiotherapy to tumor site within the last four weeks prior to dosing and with documentation of subsequent tumor growth at this site
- Patients who have received other investigational or antineoplastic medication within the last four weeks prior to dosing
- Patients who had history of esophageal variceal bleeding within eight weeks prior to study entry
- Patients who have uncontrolled diabetes, active or chronic infection, including HIV, except for asymptomatic bacterial colonization, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- Patients who had acute viral infection syndrome diagnosed within the last two weeks
- Patients who have concomitant hematological malignancy (e.g. acute lymphocytic leukemia, non-Hodgkin's lymphoma)
- Patients who have active rheumatoid arthritis or other autoimmune disease.
- Patients who have current requirement for chronic systemic immunosuppressive medication including any dose of glucocorticoid or cyclosporin, or chronic use of any such medication within the last four weeks Note: Course of glucocorticoid therapy less than 10 days duration is allowed (e.g. for nausea control)
- Patients with organ transplants (may require prolonged immunosuppressive therapy)
- Patients who had prior participation in any research protocol which involved administration of adenovirus vectors
- Patients received any immune-related related related related related blood products, such as immunoglobulin in the prior 3 months
- Patients who have uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
- Female patients that are pregnant or on breast-feeding
- Patients who receive anti-platelet agents or anti-coagulation agents (e.g. Heparin, warfarin, aspirin, ticlopidine, clopidogrel, dipyridamole and so on).
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02293850
Start Date
October 1 2014
End Date
April 1 2021
Last Update
August 20 2018
Active Locations (2)
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1
Pusan National University Hospital
Busan, South Korea, 602-739
2
National Taiwan University Hospital
Taipei, Taiwan, 10002