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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to one year for reporting.

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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