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Phase I/II Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02293850
Recruitment Status : Recruiting
First Posted : November 18, 2014
Last Update Posted : August 28, 2017
Sponsor:
Collaborator:
Medigen Biotechnology Corporation
Information provided by (Responsible Party):
Oncolys BioPharma Inc

Brief Summary:
This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative phase I/II trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 33 patients will be recruited in this study. By utilizing a Simon optimal two-stage design, up to 69 patients will be enrolled into this study, while considering the 20% drop-out rate, in order to target 19 response-evaluable patients for the first stage and additional 36 response-evaluable patients for the second stage in phase II part study.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Biological: OBP-301 Phase 1 Phase 2

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 injection in the phase I part, and 24 weeks after the last injection in the phase II part.

Each patient will return for follow-up visit weekly in the first month after the last injection, and then every 4 weeks up to the end of follow-up period of each phase.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: single intra-tumoral injection
OBP-301 ; Cohort 1: 1x10 10 viral particle (VP)/ tumor Cohort 2: 1x10 11 viral particle (VP)/ tumor Cohort 3: 1x10 12 viral particle (VP)/ tumor
Biological: OBP-301

In phase I part, a range of dose levels is investigated and the starting dose is 1x1010 VP/tumor. Dose administration will be conducted through a dose-escalating scheme from 1x1010 VP/tumor to 1x1011 VP/tumor, 1x1012 VP/tumor, 3x1011 VP/tumor and 3x1012 VP/tumor.

After assessing the clinical safety profiles by escalating doses of OBP-301 in patients with hepatocellular carcinoma, the phase II study to determine the response rate will be performed.


Experimental: multiple intra-tumoral injections
OBP-301 ; Cohort 4: 1x10 11 viral particle (VP)/ tumor x 3 times (for a total dose of 3x1011 VP/tumor) Cohort 5: 1x10 12 viral particle (VP)/ tumor x 3 times (for a total dose of 3x1012 VP/tumor)
Biological: OBP-301

In phase I part, a range of dose levels is investigated and the starting dose is 1x1010 VP/tumor. Dose administration will be conducted through a dose-escalating scheme from 1x1010 VP/tumor to 1x1011 VP/tumor, 1x1012 VP/tumor, 3x1011 VP/tumor and 3x1012 VP/tumor.

After assessing the clinical safety profiles by escalating doses of OBP-301 in patients with hepatocellular carcinoma, the phase II study to determine the response rate will be performed.





Primary Outcome Measures :
  1. Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base. [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Maximum Tolerated Dose (MTD)/ Maximum Feasible Dose (MFD) for patients using OBP-301. [ Time Frame: 16 weeks ]
  2. Dose-Limiting Toxicity (DLT) for patients using OBP-301. [ Time Frame: 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 to 65 years (19 to 65 years in Korea) in phase I part or aged 18 to 75 years (19 to 75 years in Korea) in phase II part, either sex
  2. Patients diagnosed with hepatocellular carcinoma. The diagnosis of HCC (hepatocellular carcinoma) should be established by cytology or histopathology
  3. 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
  4. 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
  5. Patients who have Child-Pugh's Score no greater than 7, and have no ascites
  6. 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
  7. Platelet count correctable to greater than or equal to 80,000 / microliter
  8. prothrombin time-international normalized ratio (PT-INR) correctable to less than 1.5
  9. Patients who have life expectancy longer than 12 weeks

Exclusion Criteria:

  1. Patients who have had chemotherapy within last three weeks (6 weeks for nitrosourea or Mitomycin-C) prior to dosing
  2. 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
  3. Patients who have received other investigational or antineoplastic medication within the last four weeks prior to dosing
  4. Patients who had history of esophageal variceal bleeding within eight weeks prior to study entry
  5. 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
  6. Patients who had acute viral infection syndrome diagnosed within the last two weeks
  7. Patients who have concomitant hematological malignancy (e.g. acute lymphocytic leukemia, non-Hodgkin's lymphoma)
  8. Patients who have active rheumatoid arthritis or other autoimmune disease.
  9. 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)
  10. Patients with organ transplants (may require prolonged immunosuppressive therapy)
  11. Patients who had prior participation in any research protocol which involved administration of adenovirus vectors
  12. Patients received any immune-related related related related related blood products, such as immunoglobulin in the prior 3 months
  13. 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
  14. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
  15. Female patients that are pregnant or on breast-feeding
  16. Patients who receive anti-platelet agents or anti-coagulation agents (e.g. Heparin, warfarin, aspirin, ticlopidine, clopidogrel, dipyridamole and so on).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293850


Contacts
Contact: Ryo Nakamura 81-3-5472-1578 nakamura@oncolys.com

Locations
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Contact: Jeong Heo         
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Pei-Jer Chen         
Sponsors and Collaborators
Oncolys BioPharma Inc
Medigen Biotechnology Corporation
Investigators
Study Chair: Pei-Jer Chen, M.D., Ph.D. National Taiwan University Hospital

Responsible Party: Oncolys BioPharma Inc
ClinicalTrials.gov Identifier: NCT02293850     History of Changes
Other Study ID Numbers: CT-OT-21
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases