Carcinoma, HepatocellularPhase 1NCT02293850
Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
A Phase 1 study testing OBP-301 in people with Carcinoma, Hepatocellular, run by Oncolys BioPharma Inc at 2 sites in 2 countries.
Trial 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 recruited in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- OBP-301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Hospital
Busan, 602-739
Jeong Heo
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Pei-Jer Chen
About this study
Official title: A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
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 recruited in this study.
Read the 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.
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.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- OBP-301
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBP-301Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| single intra-tumoral injection | Experimental | 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 Receives: Biological: OBP-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base.
Measured: 14 weeks
Secondary outcomes (2)
Maximum Tolerated Dose (MTD)/ Maximum Feasible Dose (MFD) for patients using OBP-301.
Measured: 16 weeks
Dose-Limiting Toxicity (DLT) for patients using OBP-301.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2019 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncolys BioPharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, M.D., Ph.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293850
- Sponsor's protocol ID
- CT-OT-21
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heo J, Liang JD, Kim CW, Woo HY, Shih IL, Su TH, Lin ZZ, Yoo SY, Chang S, Urata Y, Chen PJ. Safety and dose escalation of the targeted oncolytic adenovirus OBP-301 for refractory advanced liver cancer: Phase I clinical trial. Mol Ther. 2023 Jul 5;31(7):2077-2088. doi: 10.1016/j.ymthe.2023.04.006. Epub 2023 Apr 14.
PubMed 37060176
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02293850
- Acronym / sponsor ID
- CT-OT-21
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oncolys BioPharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Medigen Biotechnology Corporation
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recruited in this study.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single intra-tumoral injection | Experimental | Biological: OBP-301OBP-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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBP-301A 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. | Biological | single intra-tumoral injection |
Primary outcome
Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base.
Time frame: 14 weeks
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Derived from this study: PubMed 37060176Heo J, Liang JD, Kim CW, Woo HY, Shih IL, Su TH, Lin ZZ, Yoo SY, Chang S, Urata Y, Chen PJ. Safety and dose escalation of the targeted oncolytic adenovirus OBP-301 for refractory advanced liver cancer: Phase I clinical trial. Mol Ther. 2023 Jul 5;31(7):2077-2088. doi: 10.1016/j.ymthe.2023.04.006. Epub 2023 Apr 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Jer Chen, M.D., Ph.D. study chair
National Taiwan University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OBP-301 in people with Carcinoma, Hepatocellular, run by Oncolys BioPharma Inc at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yira Bermudez, PhD, MBA, RAC (15514442576, y.bermudez@oncolys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.