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Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TBI 302
Sponsored by
Therapure Biopharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular, Carcinoma, Liver, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients histologically or cytologically confirmed, unresectable, or metastatic HCC
  • Child-Pugh Category A or B (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites
  • Male or female patients 18 years of age or older
  • Patients must be willing and able to read, understand and sign a written informed consent form
  • Male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment
  • Life expectancy of greater than 3 months
  • Plasma haptoglobin ≥ LLN (lower limit of normal)

Exclusion Criteria:

  • Patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels
  • Patients who have received a blood transfusion within 4 weeks of enrolment
  • Patients with infiltrating diffuse hepatocellular carcinoma, Type 1 or 2 diabetes mellitus, Hepatitis B or Hepatitis C infection
  • Systemic chemotherapy-naive patients
  • Patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months
  • Patient with a history of tumor rupture
  • Patients with serious non-healing wound , ulcer or bone fracture
  • Known positive human immunodeficiency virus (HIV) test

Sites / Locations

  • Indiana University Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TBI 302 Safety, Tolerability

Arm Description

5 Cohorts, Dose escalation TBI 302 will be formulated in 0.9% saline. TBI 302 in a syringe will be administered over approximately 1 hour under constant observation once per week for 4 weeks (on Days 1, 8, 15 and 22).

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
The number of TEAEs observed during the trial

Secondary Outcome Measures

Determination of Maximum Tolerated Dose
Determination of Maximum Tolerated Dose of TBI 302

Full Information

First Posted
August 17, 2012
Last Updated
April 8, 2019
Sponsor
Therapure Biopharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03908840
Brief Title
Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma
Official Title
An Open-label, Multicenter, Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Non-resectable, Non-transplantable, Non-radiofrequency Ablation (RFA) Treatable Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapure Biopharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide. TBI 302 is being developed for the treatment of inoperable HCC by intravenous infusion. The objective is to determine the safety and tolerability of TBI 3002.
Detailed Description
This is an open-label, Phase 1 study to evaluate the safety, tolerability, PK, and MTD of TBI 302 in patients with non-resectable, non-transplantable HCC. Tumor response will be assessed at Week 9 (5 weeks following cessation of treatment) according to RECIST (ver 1.1) and AASLD criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular, Carcinoma, Liver, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBI 302 Safety, Tolerability
Arm Type
Experimental
Arm Description
5 Cohorts, Dose escalation TBI 302 will be formulated in 0.9% saline. TBI 302 in a syringe will be administered over approximately 1 hour under constant observation once per week for 4 weeks (on Days 1, 8, 15 and 22).
Intervention Type
Biological
Intervention Name(s)
TBI 302
Intervention Description
TBI 302 administered once a week in first 3 weeks and no treatment in week 4 (28 days is 1 cycle). Followed once weekly treatment of TBI 302 for 3 weeks followed by no treatment in week 4 (cycle 2)
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
Description
The number of TEAEs observed during the trial
Time Frame
through study completion, up to one year
Secondary Outcome Measure Information:
Title
Determination of Maximum Tolerated Dose
Description
Determination of Maximum Tolerated Dose of TBI 302
Time Frame
through study completion, up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients histologically or cytologically confirmed, unresectable, or metastatic HCC Child-Pugh Category A or B (score 6-7); stable, well-compensated, mild cirrhosis with minimal or no ascites Male or female patients 18 years of age or older Patients must be willing and able to read, understand and sign a written informed consent form Male, or female of childbearing potential, must agree to use double barrier contraception, oral contraceptives or other ways to avoid pregnancy during the study and for 90 days after the last day of treatment Life expectancy of greater than 3 months Plasma haptoglobin ≥ LLN (lower limit of normal) Exclusion Criteria: Patients confirmed with hemolysis confirmed by serum lactate dehydrogenase, serum haptoglobin or indirect bilirubin levels Patients who have received a blood transfusion within 4 weeks of enrolment Patients with infiltrating diffuse hepatocellular carcinoma, Type 1 or 2 diabetes mellitus, Hepatitis B or Hepatitis C infection Systemic chemotherapy-naive patients Patients with significant cardiovascular impairment, including history of congestive heart failure, unstable angina, myocardial infarction, or serious cardiac arrhythmia within the last 6 months Patient with a history of tumor rupture Patients with serious non-healing wound , ulcer or bone fracture Known positive human immunodeficiency virus (HIV) test
Facility Information:
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46077
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bert O'Neil, MD
Phone
919-593-2664
Email
bhoneil@iu.edu
First Name & Middle Initial & Last Name & Degree
Bert O'Neil, MD

12. IPD Sharing Statement

Learn more about this trial

Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma

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