drugset / Trial / NCT03195699

Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

NCT03195699

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Many patients have cancers that have increased activity of a protein called STAT3 that contributes critically to the development and growth of their cancer. Despite our knowledge of STAT3's importance to cancer, scientists and doctors have not developed a drug that targets it and that patients can take to treat their cancer more effectively than treatments that are now available. Tvardi Therapeutics, Incorporated has developed a compound, TTI-101, which can be given by mouth and acts as a direct inhibitor of STAT3. Administration of TTI-101 to mice demonstrated that it blocked growth of cancers of the breast, head and neck, lung, and liver and it was safe when administered at high doses to mice, rats, and dogs. In this application, Tvardi is proposing to further develop TTI-101 for treatment of solid tumors for which the prognosis is dismal. The investigators will determine how safe it is when administered to patients with cancer, determine whether an adequate dose can be administered to patients with cancer that will block STAT3 in their cancer, and determine whether treatment with TTI-101 leads to reduced growth of their cancer.

Timeline

Start
2017-11-15
Primary completion
2024-06-24
Completion
2024-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject C-188-9 Small molecule 3.2 mg/kg Oral
Subject C-188-9 Small molecule 6.4 mg/kg Oral
Subject C-188-9 Small molecule 12.8 mg/kg Oral
Subject C-188-9 Small molecule 25.6 mg/kg Oral