Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Hope Rugo

Description

Summary

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

Official Title

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer

Keywords

Breast Cancer Monomethyl auristatin E Antibody-drug conjugate Drug therapy Metastatic LIV-1 protein, human Trastuzumab Breast Neoplasms Immunoconjugates SGN-LIV1A SGN-LIV1A Dose Escalation SGN-LIV1A + Trastuzumab

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • University of California at San Francisco accepting new patients
    San Francisco California 94134 United States
  • UCLA Medical Center / David Geffen School of Medicine accepting new patients
    Los Angeles California 90095 United States
  • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute accepting new patients
    Los Angeles California 90048 United States

Lead Scientist

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seattle Genetics, Inc.
ID
NCT01969643
Phase
Phase 1
Study Type
Interventional
Last Updated