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Clinical Trials
Science
STAT3 is a key regulatory protein positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells as well as to the pathogenesis of many inflammatory and fibrotic diseases.
Cancer
Inhibition of STAT3 in cancer has been shown to inhibit tumorigenesis as well as reverse immunosuppression within the tumor microenvironment. TTI-101 is currently being studied in the following clinical trials:
Phase 2: TTI-101 as Monotherapy and in Combination for Hepatocellular Carcinoma - Recruiting
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: TTI-101 in Combination for Metastatic HR+ HER2- Breast Cancer - 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 ER+ HER2- palbociclib-resistant breast cancer. For more information about this ongoing trial, including research locations, please visit clinicaltrials.gov (NCT05384119)
Phase 1: TTI-101 in Advanced Cancers - Completed Recruiting
A Phase 1 open-label multicenter single agent study of TTI-101, an oral inhibitor of STAT3 in adult patients with advanced solid tumors. For more information about this ongoing trial, including research locations, please visit clinicaltrials.gov (NCT03195699)
Chronic Inflammation and Fibrosis
The pro-proliferative and pro-survival activity of STAT3 is a central mediator in chronic inflammation and fibrosis. TTI-101 is currently being studied in the following clinical trials:
Phase 2: TTI-101 in Idiopathic Pulmonary Fibrosis – Not Yet Recruiting
A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study 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)
Expanded Access to Investigational, Unapproved Medicines
We believe that our fastest path to fulfill our commitment to patients is to focus on working with the FDA to complete the required clinical studies needed to demonstrate safety and effectiveness of our investigational therapy TTI-101 for multiple cancer indications. This focus on completing our clinical trials will help us expeditiously achieve the best outcome for the greatest number of patients suffering from cancer.
Currently, Tvardi Therapeutics does not have an Expanded Access Program for any advanced cancers. We encourage patients to discuss their treatment options, including clinical trials, with their medical team.