A Safety Study of SGN-LIV1A in Breast Cancer Patients
a study on Breast Cancer
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
Description
Summary
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.
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
Breast Cancer Monomethyl auristatin E Antibody-drug conjugate Drug therapy Metastatic LIV-1 protein, human Trastuzumab Ladiratuzumab vedotin hLIV22-vcMMAE Breast Neoplasms Immunoconjugates SGN-LIV1A SGN-LIV1A Dose Escalation SGN-LIV1A + Trastuzumab
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.
- 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
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. 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
Locations
- UC San Diego / Moores Cancer Center
accepting new patients
La Jolla California 92093 United States - UCLA Medical Center / David Geffen School of Medicine
accepting new patients
Los Angeles California 90095 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Seattle Genetics, Inc.
- ID
- NCT01969643
- Phase
- Phase 1
- Study Type
- Interventional
- Last Updated
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