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REVERT Liver Cancer Clinical Trial
Phase 2: REVERT Liver Cancer Clinical Trial
TTI-101 as Monotherapy and in Combination for Hepatocellular Carcinoma (Currently Recruiting)
A Study of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
The REVERTLIVER CANCER clinical trial is evaluating the safety and effectiveness of TTI-101 orally administered in adults with hepatocellular carcinoma (HCC) alone or in combination with pembrolizumab (Keytruda®) or in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin® or biosimilars Vegzelma®, Alymsys®, Zirabev®, and Mvasi®).
TTI-101 is considered an investigational drug, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA). TTI-101 inhibits (or prevents the activity of) STAT3 (signal transducer and activator of transcription 3), a protein that plays a key role in the growth and metastasis of cancer. TTI-101 is a pill taken by mouth twice a day. While pembrolizumab, atezolizumab, and bevacizumab are FDA-approved drugs, their use in combination with TTI-101 is considered investigational.
There is no control arm or placebo in this clinical trial. All participants will receive TTI-101, either alone or in combination with pembrolizumab or with atezolizumab and bevacizumab.
REVERT Liver Cancer Clinical Trial Eligibility
The REVERTLIVER CANCER clinical trial is enrolling multiple groups of patients who may potentially benefit from TTI-101 alone or in combination. Participants who may be eligible for the REVERTLIVER CANCER clinical trial include those who have a confirmed diagnosis of locally advanced or metastatic HCC and are either:
- Naive to treatment for HCC or
- Who were previously treated with immunotherapy or
- Who were previously treated with multiple systemic therapies
REVERT Liver Cancer Clinical Trial Participation
A clinical trial doctor will evaluate participants to determine if they are eligible to join the trial. Upon enrollment, participants will receive TTI-101 alone or in combination as instructed by the treating doctor. During treatment, participants will visit the clinic and undergo medical assessments to evaluate the safety and effects of the treatment.
Clinical Trial Locations and Additional Information
If you are interested in participating and would like to learn more about the clinical trial or to find the U.S. clinical trial location nearest you, click the link below, which will redirect you to the clinicaltrials.gov website.
About Tvardi Therapeutics
The REVERTLIVER CANCER study is sponsored by Tvardi Therapeutics, a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3, a protein which has been shown to be central to the growth and metastases of liver cancer.
Read More About Tvardi Therapeutics’ Efforts To Prioritize Treatment for Patients With HCC:
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 IPF. This designation helps to expedite the 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.