Clinical Trials

Tvardi Therapeutics patient with doctor

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.


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 trial(s):

TTI-101 in Advanced Cancers – Actively Recruiting

A Phase I open-label multi center 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 (NCT03195699)

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.

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