The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Docetaxel monotherapy in a 21-day schedule. The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Docetaxel monotherapy.
Females aged 20 - 70 years old at the time of signing the ICF.
Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
ER =< 10% by immunohistochemistry (IHC) tumor staining;
PR =< 10% by IHC tumor staining;
Patient with brain metastasis.
Patient with autoimmune disease that requires systemic steroids or immunosuppression agents.
Current enrollment in another clinical study or used any investigational drug or device within the past 28 days preceding informed consent.
Patients with following treatment prior to Docetaxel monotherapy: chemotherapy, immunotherapy, or biologic systemic anticancer therapy within 21 days of study entry (42 days for mitomycin and nitrosoureas); prior taxanes; radiation therapy within 28 days (3 months for bone marrow exposure 20%); hormonal therapy within 4 weeks.