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Anti-tumor antibiotic

TH-302 Plus Doxorubicin Delivered by Trans-Arterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma

Phase 1
Waitlist Available
Led By Darren S Sigal, MD
Research Sponsored by Scripps Clinic Cancer Center
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 12 months
Awards & highlights
No Placebo-Only Group

Summary

The primary objective of this phase I dose escalation study is to determine the maximum tolerated dose of TH-302 when administered with doxorubicin via trans-arterial chemo-embolization (TACE) in patients with hepatocellular carcinoma (HCC) who are not transplant candidates and have unresectable disease. HCC is the second leading cause of worldwide cancer death and is generally incurable without liver transplant. TACE can convert about 40% of these patients to transplant candidates. Additionally, in non-transplant HCC patients, TACE confers statistical improvements in overall survival. Selective HCC arterial catheterization during TACE allows for the delivery of concentrated drugs to the liver tumor but the optimal TACE chemotherapy regimen has not yet been determined. TH-302 is a hypoxia inducible agent that can be activated in the hypoxic environment induced by TACE.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose of TH-302 use in TACE
Secondary study objectives
Objective response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase I dose level -1Experimental Treatment1 Intervention
TH-302 25mg; Doxorubicin 50mg
Group II: Phase I Dose level 2Experimental Treatment1 Intervention
TH-302 100mg; doxorubicin 50mg
Group III: Phase I Dose level 1Experimental Treatment1 Intervention
TH-302 50mg; doxorubicin 50mg
Group IV: Phase 1 Dose level 3Experimental Treatment1 Intervention
TH-302 150mg; Doxorubicin 50mg

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Who is running the clinical trial?

Scripps Clinic Cancer CenterLead Sponsor
Threshold PharmaceuticalsIndustry Sponsor
32 Previous Clinical Trials
3,845 Total Patients Enrolled
1 Trials studying Liver Cancer
24 Patients Enrolled for Liver Cancer
Darren S Sigal, MDPrincipal InvestigatorScripps Health
1 Previous Clinical Trials
4 Total Patients Enrolled
~2 spots leftby Jan 2026
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