Seattle Genetics, Inc., has announced the initiation of a phase 1 clinical trial evaluating SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer. SGN-LIV1A utilizes the company’s antibody-drug conjugate (ADC) technology. The trial is designed to assess the safety and antitumor activity of SGN-LIV1A, an ADC targeted to LIV-1 (SLC39A6), a protein which is expressed in most subtypes of metastatic breast cancer.
ADCs are designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. The open-label, dose-escalation clinical trial is enrolling patients with triple-negative disease who have previously been treated with at least two prior cytotoxic regimens in the metastatic setting, or patients with ER-positive and/or PR-positive and HER2-negative disease who have previously been treated with at least two prior cytotoxic regimens in the metastatic setting, and at least three prior hormonal therapies. The primary endpoint of the trial is safety, with key secondary endpoints of objective response, duration of response, and progression-free survival (PFS). The study is expected to enroll up to 70 patients at multiple centers in the United States.
At the American Association of Cancer Research (AACR) Annual Meeting in April 2013, preclinical data demonstrated that up to 92% of breast tumors analyzed expressed LIV-1, with limited expression in normal tissue. SGN-LIV1A demonstrated significant antitumor activity in multiple preclinical models at well-tolerated doses. Learn more about SGN-LIV1A, with links to information about other ADCs.
