Skip to main content

A Safety Study of SGN-LIV1A in Breast Cancer Patients

Trial Status: Active

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV 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.
  • Part F: All of the following:
  • Triple negative breast cancer
  • No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
  • Tumor tissue PD-L1 expression CPS <10 expression
  • Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
  • Parts E and F: Archival or fresh baseline tumor sample is required.
  • 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. Parts E and F: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
  • Prior treatment with LV 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. Boles
Phone: 858-822-5354
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Amy Nicole DeLuca
Phone: 415-353-7288

Connecticut

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

Florida

Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

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: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Hadeel Assad
Phone: 313-576-8716

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE
Rochester
Mayo Clinic in Rochester
Status: 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: ADMINISTRATIVELY_COMPLETE

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: ADMINISTRATIVELY_COMPLETE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

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
Seagen Inc.

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