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Clinical Trials Overview
Clinical Trials Overview
STAT3 (signal transducer and activator of transcription 3) is a protein known to regulate many biological functions that when overactive can promote cancer, inflammation, and fibrosis. TTI-101 is a STAT3 inhibitor (blocks the activity of STAT3) that is taken by mouth in a tablet form. Tvardi is currently sponsoring clinical trials in cancer and fibrosis using TTI-101.
Phase 1 and Phase 2: Cancer Clinical Trials
Inhibition of STAT3 in cancer has been shown to stop cancer growth as well as reverse immunosuppression, a mechanism which allows the body’s natural ability to fight cancer. STAT3 is known to be elevated in many cancers.
Phase 2: Pulmonary Fibrosis Clinical Trial
Continuous activation of STAT3 is know to lead to chronic inflammation and fibrosis.
Table of Contents:
Phase 2: REVERT Liver Cancer Clinical Trial
TTI-101 as Monotherapy and in Combination for Hepatocellular Carcinoma or Liver Cancer
(Currently Recruiting)
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A Phase 1b/2 multicenter, open-label study of TTI-101 as monotherapy and added to either pembrolizumab or atezolizumab + bevacizumab in adult patients with locally advanced or metastatic, and unresectable hepatocellular carcinoma. For more information about this ongoing trial, including research locations, please visit clinicaltrials.gov (NCT055440708)
Phase 2: REVERT Breast Cancer Clinical Trial
TTI-101 in combination for Stage 4 Metastatic HR+ HER2- Breast Cancer
(Currently Recruiting)
A Phase 1b/2 multicenter, open-label multiple-dose study of TTI-101 added to palbociclib and aromatase inhibitor (AI) therapy in adult patients with HR+ HER2- palbociclib-resistant breast cancer. For more information about this ongoing trial, including research locations, please visit clinicaltrials.gov (NCT05384119)
Phase 2: REVERT IPF Clinical Trial
TTI-101 in Idiopathic Pulmonary Fibrosis
(Currently Recruiting)
A Phase 2 multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TTI-101 in participants with idiopathic pulmonary fibrosis. For more information about this ongoing trial, including research locations, please visit clinicaltrials.gov (NCT05671835)
Phase 1: First-in-Human TTI-101 Clinical Trial
TTI-101 in Advanced Cancers
(Completed Recruiting)
A Phase 1 open-label multicenter single agent clinical trial of TTI-101, an oral inhibitor of STAT3 in adult patients with advanced solid tumors. For more information about this closed trial that has completed recruiting, please visit clinicaltrials.gov (NCT03195699)
About Tvardi Therapeutics
Tvardi Therapeutics is a private, clinical stage biotechnology company developing a new class of breakthrough medicines for diverse cancers and chronic inflammatory and fibrotic diseases. Tvardi is focused on the development of orally delivered, small molecule inhibitors of STAT3, a key signaling molecule positioned at the intersection of many disease pathways.