Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

Prior treatment

• Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
• Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
• Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer.
• Major surgery within 4 weeks of starting study treatment.
• Ongoing immunosuppressive therapy including systemic corticosteroids.
• Concurrent disease or condition that would interfere with study participation

Other illness

• History of severe cutaneous reactions.
• Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation

Other

• Patient with symptomatic uncontrolled brain metastasis.
• Pregnancy or lactation.

• Patients who have histologically confirmed TNBC.
• Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting.
• Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted.
• ECOG performance status 0 to 2.
• Adequate bone marrow, liver, and renal function