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A Safety Study of SGN-LIV1A in Breast Cancer Patients

Trial Status: Active

This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given alone or in combination with trastuzumab.

Inclusion Criteria

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
  • One of the following:
  • Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
  • Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
  • Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
  • Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
  • Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
  • Parts A, B, C, and D: Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • Part E: Archival baseline tumor sample is required; a fresh biopsy sample may be submitted in place of an archival sample if medically feasible.
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Combination Arm: adequate heart function

Exclusion Criteria

  • Pre-existing neuropathy Grade 2 or higher
  • Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Part E: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
  • Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
  • Combination Arm: hypersensitivity to trastuzumab

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Andres Forero-Torres
Phone: 205-934-0309

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Sa-Heim Davis
Phone: 310-825-4494
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL
Contact: Sarah G. Montross Boles
Phone: 858-822-5354
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: Amy Nicole DeLuca
Phone: 415-353-7288

Connecticut

New Haven
Yale University
Status: ACTIVE
Contact: Lajos Pusztai
Phone: 203-785-5702

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Cheryl Arcigal Young
Phone: 410-328-8611

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Ian Elliott Krop
Phone: 877-442-3324

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Hadeel Assad
Phone: 313-576-8716

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Rochester
Mayo Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Minetta C. Liu
Phone: 507-538-7623

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Shanu Modi
Phone: 212-639-7202
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Jennifer Marie Specht
Phone: 800-804-8824

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Seattle Genetics

  • Primary ID SGNLVA-001
  • Secondary IDs NCI-2013-02245
  • Clinicaltrials.gov ID NCT01969643