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
The purpose of this study is to test the safety and side effects of SGN-LIV1A and pembrolizumab when used together, as well as how well they work against triple negative breast cancer that has spread to other parts of the body. Investigators may test different doses of SGN-LIV1A to find the best one to use with pembrolizumab.
- Evaluate the safety and tolerability of the combination of SGN-LIV1A and pembrolizumab in patients with locally-advanced or metastatic, triple-negative breast cancer (LA/M TNBC).
- Identify the recommended dose of SGN-LIV1A in combination with pembrolizumab in patients with LA/MTNBC.
- Evaluate confirmed objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of the combination of SGN-LIV1A and pembrolizumab in patients with LA/M TNBC.
Metastatic or locally-advanced, histologically documented triple-negative breast cancer (TNBC) (absence of human epidermal growth factor receptor 2 (HER2), and expression)
Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced or metastatic (LA/M) breast cancer
At least 6 months since prior treatment with curative intent and recurrence
At least 1 tumor 10 mm 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 adequate tissue obtained recently from a tumor lesion for biomarker analysis, Core needle or excisional biopsy is preferred. If neither is possible, biopsy obtained via alternative methods may be appropriate.
Meet baseline laboratory data criteria
Not pregnant. Must agree not to become pregnant until at least 6 months after ceasing study treatment.
Must provide written informed consent if they are able to. If the patient is unable to provide written informed consent, then written informed consent can be provide by a legally authorized representative (LAR) in accordance with local legal requirements.
Radiological evidence of central nervous system (CNS) metastases
History of carcinomatous meningitis or active CNS metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline for at least 4 weeks prior to enrollment. In addition, patients must be completely off corticosteroids.
History of leptomeningeal carcinomatosis.
Active infection requiring systemic treatment 7 days or less before dose of study drug. Routine antimicrobial prophylaxis is permitted.
Active autoimmune disease requiring systemic treatment within the past 2 years
Known positive for hepatitis B, active hepatitis C or known history of being seropositive for HIV. Patients who has been treated for hepatitis C are permitted if they have documented sustained virologic response of 12 weeks.
Documented history of a cerebral vascular event.
Ongoing clinically significant toxicity associated with prior treatment including systemic therapy, radiotherapy or surgery.
Has received prior radiotherapy within 2 weeks of start of study treatment. A patient is also excluded if radiotherapy occurred more than 2 weeks prior to start of study treatment but the patient has not recovered from radiation related toxicities, requires corticosteroids, or has had radiation pneumonitis.
History of interstitial lung disease
Current pneumonitis or history of pneumonitis requiring steroids
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of corticosteroids for physiological replacement may be approved.
Patients who are breastfeeding, pregnant or planning to become pregnant from time of informed consent until 6 months after final dose of study drug administration.
Known hypersensitivity to any excipient contained in the drug formulation of SGN-LIVIA or pembrolizumab.
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