A Safety Study of SGN-LIV1A in Breast Cancer Patients

  • Interventional
  • Not Recruiting
  • NCT01969643
Eligibility Details Visit Clinicaltrials.gov

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer

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.

Gender
Female

Age Group
18 Years and up

Accepting 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

At a Glance

National Government IDNCT01969643

IRB#IRB16-1383

Lead SponsorSeattle Genetics, Inc.

Lead PhysicianRita Nanda

Collaborator(s)N/A

EligibilityFemale
18 Years and up
Not Recruiting