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A phase 1, open-label, dose-escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer
This study is being done to find out what side effects (unwanted effects) are caused in participants with breast cancer who are given SGN-LIV1A (single therapy). This study will also look at other effects of SGN-LIV1A, including its effect on this type of cancer. This study is also being done to find out what side effects (unwanted effects) are caused in participants with HER2-positive breast cancer who are given SGN-LIV1A in combination with trastuzumab (combination therapy).
Primary Objectives: - To evaluate the safety and tolerability of SGN-LIV1A in patients with LIV-1-positive, incurable, unresectable, LA/MBC. - To identify the maximum tolerated dose (MTD) of SGN-LIV1A, if one exists among doses tested. - To evaluate the safety and tolerability of treatment with SGN-LIV1A given in combination with trastuzumab to patients with HER2-positive- and LIV-1-positive LA/MBC (Part B only). Secondary Objectives: - To assess the pharmacokinetics (PK) of SGN-LIV1A. - To assess the immunogenicity of SGN-LIV1A. - To assess the antitumor activity of SGN-LIV1A. Additional Objectives: - To assess exploratory biomarkers of SGN-LIV1A-mediated pharmacodynamic effects and to evaluate LIV-1 expression in tumor tissue. - To evaluate the LIV-1 expression-response relationship following treatment with SGN-LIV1A.
Herceptin (Trastuzumab); SGN-LIV1A (); Trastuzumab (); rhuMAb HER2 (Trastuzumab)