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

Phase 1

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT03908840
• Lead Sponsor: Therapure Biopharma Inc

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.

Study Timeline

• Study First Submitted: 2012-08-17
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Study First Posted: 2019-04-09
• Last Update Posted: 2019-04-09
• Study Start: 2019-12
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial	through study completion, up to one year	The number of TEAEs observed during the trial

Secondary Outcome Measures

Name	Time	Method
Determination of Maximum Tolerated Dose	through study completion, up to one year	Determination of Maximum Tolerated Dose of TBI 302

Trial Locations

Locations (1)

Indiana University Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States