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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02293850
• Date of registration: 13/11/2014
• Prospective Registration: No
• Primary sponsor: Oncolys BioPharma Inc
• Public title: Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
• Scientific title: A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
• Date of first enrolment: October 2014
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02293850
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Korea, Republic of, Taiwan

Contacts

• Name: Pei-Jer Chen, M.D., Ph.D.
• Affiliation: National Taiwan University Hospital

• Name: Yira Bermudez, PhD, MBA, RAC

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients aged 18 to 65 years (19 to 65 years in Korea), 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Hepatocellular

Intervention(s)

Biological: OBP-301

Primary Outcome(s)

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

Secondary Outcome(s)

Maximum Tolerated Dose (MTD)/ Maximum Feasible Dose (MFD) for patients using OBP-301. [Time Frame: 16 weeks]

Dose-Limiting Toxicity (DLT) for patients using OBP-301. [Time Frame: 28 weeks]

Secondary ID(s)

CT-OT-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medigen Biotechnology Corporation