A Safety Study of SGN-LIV1A in Breast Cancer Patients

a study on Breast Cancer

Summary

for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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.

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 CancerMonomethyl auristatin EAntibody-drug conjugateDrug therapyMetastaticLIV-1 protein, humanTrastuzumabLadiratuzumab vedotinhLIV22-vcMMAEBreast NeoplasmsImmunoconjugatesSGN-LIV1ASGN-LIV1A Dose EscalationSGN-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

  • UC San Diego / Moores Cancer Center accepting new patients
    La JollaCalifornia92093United States
  • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute accepting new patients
    Los AngelesCalifornia90048United States

Details

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