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

Therapure Biopharma

Status and phase: Unknown; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: TBI 302

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908840

TBI 302-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

TBI 302 Safety, Tolerability

Experimental group

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).

Treatment:

Biological: TBI 302