Phase I 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 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Hepatocellular||Biological: OBP-301||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma|
|Actual Study Start Date :||October 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2021|
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
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.
- Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base. [ Time Frame: 14 weeks ]
- 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 ]
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
|Contact: Yira Bermudez, PhD, MBA, RACfirstname.lastname@example.org|
|Korea, Republic of|
|Pusan National University Hospital||Recruiting|
|Busan, Korea, Republic of, 602-739|
|Contact: Jeong Heo|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 10002|
|Contact: Pei-Jer Chen|
|Study Chair:||Pei-Jer Chen, M.D., Ph.D.||National Taiwan University Hospital|