Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
• Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
⁃ Part D only: Tumor tissue PD-L1 Combined Positive Score \<10 expression.
• Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
• At least 6 months since prior treatment with curative intent and recurrence
• At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Able to provide biopsy tissue for biomarker analysis
• Meet baseline laboratory data criteria