A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma (NCT05440708)
REVERT- Liver Cancer: A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
🩺 Plain-English Summary (8th-Grade Level)
The primary objectives of Cohort A Phase 1b and exploratory expansion are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent to participants with locally advanced or metastatic, and unresectable Hepatocellular Carcinoma (HCC) and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of TTI-101 as a single agent. The primary objectives of Cohort A Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered as a single agent at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 as a single agent in participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohort A Phase 2 are to assess response, progression, survival, and pharmacokinetics. The primary objectives of Cohorts B and C Phase 1b are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, or unresectable HCC and to determine the MTD and/or RP2D of TTI-101 when used in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C). The primary objectives of Cohorts B and C Phase 2 are to evaluate the safety and tolerability of TTI-101 orally administered in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) at the RP2D to participants with locally advanced or metastatic, and unresectable HCC and to assess the preliminary efficacy of TTI-101 in combination with pembrolizumab therapy (Cohort B) and in combination with atezolizumab and bevacizumab therapy (Cohort C) to participants with locally advanced or metastatic, and unresectable HCC. The secondary objectives of Cohorts B and C Phase 2 are to assess response, progression, survival, and pharmacokinetics.
Who can join: Review the eligibility criteria below.
Location: The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham, Alabama
- University of California San Diego — La Jolla, California
- Norris Comprehensive Cancer Center — Los Angeles, California
- University of California Irvine Medical Center — Orange, California
- University of Colorado Hospital - Anschutz Medical Campus — Aurora, Colorado
- Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia
- Moffitt Cancer Center — Tampa, Florida
- The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan
- Washington University in St. Louis — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center - New York — New York, New York
- Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- Harold C. Simmons Comprehensive Cancer Center — Dallas, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas
- DHR Health Institute for Research and Development — McAllen, Texas
- University of Texas Health Science Center - San Antonio — San Antonio, Texas
- Virginia Mason Medical Center — Seattle, Washington
- Summit Cancer Centers - North Spokane — Spokane, Washington
- Froedtert and Medical College of Wisconsin — Milwaukee, Wisconsin
📞 Contact the Study Coordinator
Phone: (205) 767-7914
Email: klsaxton@uabmc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Hepatocellular Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.