∙ Dose Escalation and Dose Expansion Cohorts

∙ Patients must meet all of the following criteria to be eligible for participation in the study:

• Female patients, ≥ 18 years of age at the time of obtaining informed consent.

• Patients with a documented (histologically- or cytologically-proven) breast cancer that is locally advanced or metastatic.

• Patients with a malignancy that is either relapsed/refractory to standard therapy or for which no standard therapy is available.

• Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.

• Patients with measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1).

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (see APPENDIX B: Performance Status Evaluation).

• Life expectancy of greater than or equal to 3 months.

• Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2).

• Patients who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and during 3 months after the last dose of study drug. (See Appendix H: Forms of contraception).

⁃ Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

∙ Dose expansion Cohort - TNBC

• Patients with conditions as follows:

‣ ER \<10%, PR \<10% by IHC assay; And

⁃ HER2 negative based on ASCO CAP guideline

• Patients with measurable disease according to the response evaluation criteria in TNBC (RECIST, v1.1)

• Patients with measurable disease that can be easily accessed for biopsy.

• Relapsed (recurrence or disease progression after achieving a documented clinical response to first- or second-line treatment) or refractory (disease progression while receiving first line or second line treatment). In the case of TNBC, prior initial therapy with at least one known active regimen for TNBC including, but not limited to, any combination of anthracyclines, taxanes, platinum agents, Ixabepilone, and/or cyclophosphamide is required.