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Virus Therapy
Open-label Multicenter Phase 1 Study of TBI 302 as Second-Line Therapy in Patients With Hepatocellular Carcinoma
Phase 1
Waitlist Available
Research Sponsored by Therapure Biopharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to one year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests TBI 302, an IV drug for liver cancer that can't be surgically removed. It focuses on patients who can't have surgery or a transplant. The study will check safety, patient tolerance, and the best dose, as well as whether the drug helps shrink tumors.
Eligible Conditions
- Liver Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
Secondary study objectives
Determination of Maximum Tolerated Dose
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TBI 302 Safety, TolerabilityExperimental Treatment1 Intervention
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).
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Who is running the clinical trial?
Therapure Biopharma IncLead Sponsor
1 Previous Clinical Trials
74 Total Patients Enrolled