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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

Conditions

Breast - Female

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

This study is being conducted to examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer, and to find the highest dose of the drug that can be given without unacceptable side effects. Other goals of the trial are to find out if SGN-LIV1A has any antitumor effects, to learn about the pharmacokinetics of SGN-LIV1A, and to explore the relationship between antigen expression and SGN-LIV1A effects.


Participation Guidelines

Age:
18 Years and older
Gender:
Female

Eligibility Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of metastatic disease
  • One of the following: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the metastatic setting or b) ER- and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the metastatic setting and are no longer a candidate for hormonal therapy
  • Positive for LIV-1 expression by central pathology review on newly obtained tumor tissue biopsy
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1

Exclusion Criteria:

  • Pre-existing neuropathy Grade 2 or higher
  • Malignant CNS disease that has not been definitively treated
  • P-gp inducers/inhibitors or strong CYP3A inducers/inhibitors within 2 weeks before first dose
Sponsor:
Seattle Genetics, Inc.
Dates:
06/26/2014
Last Updated:
Study HIC#:
1311013056