NCT02293850

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 recruited in this study.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

4.5 years

First QC Date

November 13, 2014

Last Update Submit

August 16, 2018

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

  • Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base.

    14 weeks

Secondary Outcomes (2)

  • Maximum Tolerated Dose (MTD)/ Maximum Feasible Dose (MFD) for patients using OBP-301.

    16 weeks

  • Dose-Limiting Toxicity (DLT) for patients using OBP-301.

    28 weeks

Study Arms (1)

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

Biological: OBP-301

Interventions

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.

single intra-tumoral injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pusan National University Hospital

Busan, 602-739, South Korea

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37060176DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Pei-Jer Chen, M.D., Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Yira Bermudez, PhD, MBA, RAC

CONTACT

15514442576y.bermudez@oncolys.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

November 18, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2021

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

TW(1)KR(1)