A Safety Study of SGN-LIV1A in Breast Cancer Patients
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-007529
NCT ID: NCT01969643
Sponsor Protocol Number: SGNLVA-001
About this study
This study is being conducted to examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer, and to find the highest dose of the drug that can be given without unacceptable side effects. Other goals of the trial are to find out if SGN-LIV1A has any antitumor effects, to learn about the pharmacokinetics of SGN-LIV1A, and to explore the relationship between antigen expression and SGN-LIV1A effects.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Pathologically confirmed diagnosis of breast cancer with radiographic evidence of metastatic disease
- One of the following: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the metastatic setting; or b) ER- and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the metastatic setting and are no longer a candidate for hormonal therapy
- Positive for LIV-1 expression by central pathology review on newly obtained tumor tissue biopsy
- Measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1
- Pre-existing neuropathy Grade 2 or higher
- Malignant CNS disease that has not been definitively treated
- P-gp inducers/inhibitors or strong CYP3A inducers/inhibitors within 2 weeks before first dose
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Minetta Liu, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office