REVERT Liver Cancer Clinical Trial
Tvardi Clinical Trials
Phase 2 Clinical Trial:
TTI-101 as Monotherapy and in Combination for Hepatocellular Carcinoma or Liver Cancer
The REVERT Liver Cancer Clinical Trial
The REVERT liver cancer study is a Phase 2 clinical trial evaluating TTI-101 as a new treatment for a type of liver cancer known as hepatocellular carcinoma (HCC) as a single agent or in combination with other drugs in participants with HCC that is locally advanced or metastatic.
FDA Grants Orphan Drug Designation to TTI-101 for Hepatocellular Carcinoma
In 2022 the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to TTI-101 as a drug that shows promise in treating HCC. This designation helps to expedite clinical development of TTI-101.
FDA Grants Fast Track Designation to TTI-101 for Hepatocellular Carcinoma
In 2022 the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to TTI-101 as a drug that shows promise in treating HCC, a serious condition with unmet need. Fast Track designation aids in the expedited development and review of TTI-101 for use in HCC.
What is Hepatocellular Carcinoma or HCC?
Hepatocellular Carcinoma or HCC is the most common form of liver cancer and is a major contributor to the worldwide cancer burden, affecting fewer than 200,000 people in the US. Incidence rates of this disease have increased in many countries in recent decades, and liver cancer has been a relatively chemotherapy-refractory or treatment resistant tumor.
Unresectable HCC is HCC tumor that is unable to be surgically removed.
Metastatic HCC is HCC that has spread beyond the liver into other organs or lymph nodes.
Locally advanced HCC is HCC that has spread beyond the liver but has not yet spread to other organs or lymph nodes.
Who May be Eligible to Participate in the Clinical Trial?
If you are an adult with locally advanced or metastatic, and unresectable hepatocellular carcinoma you may be eligible to participate in our clinical trial. Please contact your preferred active clinical trial location to confirm eligibility criteria.
What Can You Expect if You Participate in the Clinical Trial?
- All participants in the clinical trial will receive the clinical trial drug, TTI-101, either alone or in combination with pembrolizumab (Keytruda®) or with atezolizumab (Tecentriq®) plus bevacizumab (Avastin®).
- TTI-101 is an investigational drug, meaning it is not currently approved by the US Food and Drug Administration (FDA). While pembrolizumab, atezolizumab, and bevacizumab are FDA-approved drugs, their use in combination with TTI-101 is also considered investigational.
- Your participation in this clinical trial will include 3 periods: Screening, Study Treatment, and Follow-up. During the Screening Period, your doctor will perform tests to find out if you are eligible to take the study treatment given during the REVERT Clinical Trial. If you are eligible, you will be assigned to 1 of 3 treatment groups. One of the treatment groups will receive only TTI-101, while the other 2 groups will receive TTI-101 in combination with FDA-approved drugs to treat liver cancer. You will continue on treatment unless your cancer progresses, you decide to leave the clinical trial, or the clinical trial ends. Four weeks after the last dose, you will be asked to return for a follow-up visit, and after that, clinical trial staff will check in with you every 12 weeks.
TTI-101 is taken by mouth and is a STAT3 inhibitor, meaning that it reduces STAT3 activity. STAT3 is a key protein known to regulate many biological functions that when overactive can promote tumor growth and fibrosis, both of which often contribute to the development and progression of HCC.
Interested in Participating at One of Our Active Sites?
Please reach out to find participating sites amongst multiple U.S. locations. Please contact one of the active sites listed on clinicaltrials.gov to see if you are eligible to participate in this clinical trial: Find out more today at clinicaltrials.gov.
About Tvardi Therapeutics
The REVERT liver cancer clinical trial is sponsored by Tvardi Therapeutics, a privately held, clinical-stage biopharmaceutical company developing small-molecule inhibitors of STAT3. TTI-101 as a STAT3 inhibitor reduces STAT3 activity. STAT3 is a key protein involved in many biological functions that, when overactive, can promote tumor growth and fibrosis, which often contribute to the development and progression of liver cancer. We are studying new and more effective ways to treat HCC using oral medication of TTI-101.