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

Status unconfirmed · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT03908840

Run by

Evolve Biologics

People needed

12

Starts

2019-12-01

Expected to finish

2021-03-01

Last updated by the study team

2019-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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