A new phase 1 clinical trial evaluating SGN-LIV1A for patients with LIV-1-positive metastatic breast cancer has started. SGN-LIV1A utilizes Seattle Genetics’ industry-leading 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.
SGN-LIV1A is one of four ADCs Seattle Genetics is advancing into the clinic during 2013, demonstrating the company’s significant investment in this approach for the treatment of cancer.
The study is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and antitumor activity of SGN-LIV1A in patients with LIV-1-positive metastatic breast cancer. The 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 percent 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 (AACR 2013 Abstract 3962).