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

NCT03908840 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: TBI 302-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular; Carcinoma; Liver; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determination of Maximum Tolerated Dose

  through study completion, up to one year

Study Arms (1)

TBI 302 Safety, Tolerability

EXPERIMENTAL

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

Interventions

TBI 302 BIOLOGICAL

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)

TBI 302 Safety, Tolerability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Therapure Biopharma Inc: lead

Study Sites (1)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46077, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: April 9, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 9, 2019

Record last verified: 2019-04

Locations

US (1)