A Safety Study of SGN-LIV1A in Breast Cancer Patients

Status: Active

Description

This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

Eligibility Criteria

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) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
  • Part E) ER-positive and/or PR-positive/HER2- disease and received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting.
  • Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • 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
  • Malignant CNS disease that has not been definitively treated
  • Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
  • Combination Arm: hypersensitivity to trastuzumab

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Sa-Heim Davis
Phone: 310-825-4494
Email: sjdavis@mednet.ucla.edu
San Diego
University of California San Diego
Status: Active
Contact: Sarah G. Montross Boles
Phone: 858-822-5354
Email: cancercto@ucsd.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Amy Nicole DeLuca
Phone: 415-353-7288
Email: amy.deluca@ucsf.edu

Connecticut

New Haven
Yale University
Status: Active
Contact: Lajos Pusztai
Phone: 203-785-5702
Email: lajos.pusztai@yale.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Cheryl Arcigal Young
Phone: 410-328-8611
Email: Cheryl.young@umm.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Contact: Ian Elliott Krop
Phone: 877-442-3324
Email: ikrop@partners.org

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: Approved
Name Not Available
Rochester
Mayo Clinic
Status: Active
Contact: Minetta C. Liu
Phone: 507-538-7623
Email: liu.minetta@mayo.edu

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Shanu Modi
Phone: 212-639-7202
Email: modis@mskcc.org
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Contact: Jennifer Marie Specht
Phone: 800-804-8824
Email: jspecht@uw.edu

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Seattle Genetics

Trial IDs

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