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Clinical Trial 18862
Cancer Type: Breast
Interventions:Herceptin (Trastuzumab); SGN-LIV1A; Trastuzumab; rhuMAb HER2 (Trastuzumab)
Study Type: Treatment
Phase of Study: Phase I
- Heather Han
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with LIV-1-Positive 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.