A Safety Study of SGN-LIV1A in Breast Cancer Patients

Inclusion Criteria

• •Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
• •One of the following:
• •* Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
• •* Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
• •* Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
• •* Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
• •* Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
• •Part F: All of the following:
• •* Triple negative breast cancer
• •* No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
• •* Tumor tissue PD-L1 expression CPS \<10 expression
• •Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
• •Parts E and F: Archival or fresh baseline tumor sample is required.
• •Measurable disease
• •Eastern Cooperative Oncology Group performance status 0 or 1
• •Combination Arm: adequate heart function