A Safety Study of SGN-LIV1A in Breast Cancer Patients
a study on Breast Cancer HER2 Triple-Negative Breast Cancer Neoplasms
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UCLA UCSD UCSF
- Dates
- study startedestimated completion
Description
Summary
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.
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
HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms, Monomethyl auristatin E, Antibody-drug conjugate, Drug therapy, Metastatic, LIV-1 protein, human, Trastuzumab, Ladiratuzumab vedotin, hLIV22-vcMMAE, Seattle Genetics, Neoplasms, Breast Neoplasms, LV + Trastuzumab, LV Monotherapy
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.
- 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 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. 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
Locations
- UC San Diego / Moores Cancer Center
La Jolla California 92093 United States - University of California at San Francisco
San Francisco California 94134 United States - UCLA Medical Center / David Geffen School of Medicine
Santa Monica California 90404 United States - Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles California 90048 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Seagen Inc.
- ID
- NCT01969643
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- About 290 people participating
- Last Updated