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

Hepatocellular Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03908840
• Other study ID #: TBI 302-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2019
• Est. completion date: March 2021

Study information

• Verified date: April 2019
• Source: Therapure Biopharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• 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)

Locations

Country	Name	City	State
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Therapure Biopharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determination of Maximum Tolerated Dose	Determination of Maximum Tolerated Dose of TBI 302	through study completion, up to one year