Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SGN-LIV1A Dose Escalation
  • Drug: SGN-LIV1A
    SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks
Experimental
SGN-LIV1A + Trastuzumab
  • Drug: SGN-LIV1A
    SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks
  • Drug: Trastuzumab
    Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
    Other names:
    • Herceptin
Experimental
SGN-LIV1A
SGN-LIV1A will be given at the recommended dose (at or below the monotherapy MTD determined in the SGN-LIV1A dose escalation arm).
  • Drug: SGN-LIV1A
    SGN-LIV1A will be given by intravenous infusion (into the vein; IV) every 3 weeks
  • Drug: Trastuzumab
    Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
    Other names:
    • Herceptin

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com

More Details

NCT ID
NCT01969643
Status
Recruiting
Sponsor
Seattle Genetics, Inc.

Study Contact

Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.