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Virus Therapy
TBI 302 Safety, Tolerability for Liver Cancer
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
Study 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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) observed during the trial
Secondary outcome measures
Determination of Maximum Tolerated Dose
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
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