A Safety Study of SGN-LIV1A in Breast Cancer Patients

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 alone or in combination with trastuzumab.

Condition

  • Breast Cancer

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 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.
  • Parts A, B, C, and D: Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • Part E: Archival baseline tumor sample is required; a fresh biopsy sample may be submitted in place of an archival sample if medically feasible.
  • 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
  • Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Part E: Known or suspected cerebral/meningeal metastasis 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)
Experimental
SGN-LIV1A + Trastuzumab
  • Drug: SGN-LIV1A
    SGN-LIV1A will be given by intravenous infusion (into the vein; IV)
  • 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)
  • 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 35249
Contact:
Seattle Genetics Trial Information Support
866-333-7436
clinicaltrials@seagen.com

More Details

Status
Recruiting
Sponsor
Seattle Genetics, Inc.

Study Contact

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