A Safety Study of SGN-LIV1A in Breast Cancer Patients

Completed · Phase 1

Conditions studied: HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT01969643

Run by

Seagen Inc.

People needed

290

Starts

2013-10-22

Expected to finish

2023-02-04

Last updated by the study team

2023-03-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
• UC San Diego / Moores Cancer Center — La Jolla, California, United States
• Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• UCLA Medical Center / David Geffen School of Medicine — Santa Monica, California, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• Poudre Valley Health System (PVHS) — Fort Collins, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• The Whittingham Cancer Center / Norwalk Hospital — Norwalk, Connecticut, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Piedmont Cancer Institute — Atlanta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Allina Health Cancer Institute — Minneapolis, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University in St Louis — St Louis, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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