TRANSTHERA-B (02617): The first patient in Phase II clinical trial of combination of Enzalutamide and Fulvestrant in hormone receptor-positive/human epidermal growth factor receptor 2-negative recurrent or metastatic breast cancer patients who have failed prior treatments has completed dosing.

TRANSTHERA-B (02617) announced that the Phase II clinical study of the company's core product, Tenengotinib (TT-00420) in combination with Fluvisquine, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative or low-expression (HER2-) recurrent or metastatic breast cancer patients who have failed prior therapy, has recently completed dosing for the first patient. This trial is an open, multicenter, Phase II clinical study being conducted in China to evaluate the safety, efficacy, and pharmacokinetics of Tenengotinib in combination with Fluvisquine injection for patients with HR+/HER2- recurrent or metastatic breast cancer who have failed standard treatments including endocrine therapy and CDK4/6 inhibitors. The main target population of this study is patients who have failed standard treatments and are in need of new therapeutic options. The study aims to explore the clinical value of the combination therapy of Tenengotinib and Fluvisquine for this resistant population of breast cancer patients. Breast cancer is one of the most common malignancies in women globally, with the HR+/HER2- subtype accounting for approximately 70% of all breast cancer patients. This subgroup of patients is prone to developing drug resistance and recurrent disease after standard treatments, highlighting the urgent need for new effective treatment options. Early clinical results of Tenengotinib have shown promising clinical efficacy as a monotherapy in HR+/HER2- breast cancer patients who have received multiple treatments, supporting further development of its combination with endocrine therapy.