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

NCT ID: NCT03908840

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2021-03-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TBI 302 Safety, Tolerability

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).

Group Type: EXPERIMENTAL

TBI 302

Intervention Type: BIOLOGICAL

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)

Interventions

TBI 302

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)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapure Biopharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Facility Contacts

Bert O'Neil, MD

Role: primary

bhoneil@iu.edu

919-593-2664

Other Identifiers

TBI 302-001

Identifier Type: -

Identifier Source: org_study_id