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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: TBI 302


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TBI 302 Safety, Tolerability<br>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). | Biological: TBI 302<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Maximum Tolerated Dose | Determination of Maximum Tolerated Dose of TBI 302 | through study completion, up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular, Carcinoma, Liver, Cancer