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Beta-catenin Inhibitor
Tegavivint + Pembrolizumab for Liver Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Iterion Therapeutics
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 tumors will be assessed at baseline and every 8 weeks until end of treatment, an average of 1 year
Awards & highlights
Study Summary
This trial will test a new drug to treat advanced liver cancer after other treatments have failed. It will also study the drug combined with another medicine.
Who is the study for?
Adults with advanced liver cancer (HCC) who've had at least one prior systemic therapy can join. They must have measurable disease, certain blood and organ function levels, controlled hepatitis B or cured hepatitis C, and no severe heart issues. Pregnant women and those with other active cancers or recent major surgeries cannot participate.Check my eligibility
What is being tested?
The trial has two parts: first testing Tegavivint alone in different doses for HCC patients after other treatments failed; second combining Tegavivint with Pembrolizumab to find the best dose. Participants are chosen based on specific genetic markers in their tumors.See study design
What are the potential side effects?
Possible side effects include immune system reactions, fatigue, digestive problems, skin changes, potential heart rhythm issues due to Tegavivint's effect on cells' signaling pathways. Pembrolizumab may cause similar immune-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tumors will be assessed at baseline and every 8 weeks until end of treatment, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumors will be assessed at baseline and every 8 weeks until end of treatment, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate efficacy of tegavivint as a single agent
Incidence of Treatment-Related Adverse Events
Number of participants with dose limiting toxicities
Other outcome measures
Evaluate efficacy of combination of tegavivint plus pembrolizumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: Tegavivint single agent dosing regimenExperimental Treatment1 Intervention
Tegavivint as monotherapy
Group II: Tegavivint plus pembrolizumab combination dosing regimenExperimental Treatment2 Interventions
Tegavivint in combination with pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tegavivint
2018
Completed Phase 1
~30
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Iterion TherapeuticsLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program searching for new participants?
"Indeed, the information hosted on clinicaltrials.gov confirms that this research endeavour is currently recruiting participants. This project was first posted on September 13th 2023 and has been amended since then; it seeks 108 members from 8 medical sites in total."
Answered by AI
How many individuals are engaged in this particular research project?
"This clinical trial necessitates 108 suitable patients to enrol. Individuals can join at Sylvester Comprehensive Cancer Center in Miami, Florida or University of Chicago in Chicago, Illinois - both approved locations for the study."
Answered by AI
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