Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
estimated completion

Description

Summary

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.

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

HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms, Monomethyl auristatin E, Antibody-drug conjugate, Drug therapy, Metastatic, LIV-1 protein, human, Trastuzumab, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics, Neoplasms, Breast Neoplasms, LV + Trastuzumab, LV Monotherapy

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 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

You CAN'T join if...

  • 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

Locations

  • UC San Diego / Moores Cancer Center
    La Jolla California 92093 United States
  • University of California at San Francisco
    San Francisco California 94134 United States
  • UCLA Medical Center / David Geffen School of Medicine
    Santa Monica California 90404 United States
  • Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT01969643
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 290 people participating
Last Updated