A Safety Study of SGN-LIV1A in Breast Cancer Patients

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    508
  • sponsor
    Seagen Inc.
Updated on 11 June 2021
measurable disease
endocrine therapy
metastasis
hormone therapy
HER2
trastuzumab
triple negative breast cancer
stage iv breast cancer
erbb2
mammogram

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Trastuzumab, SGN-LIV1A, ladiratuzumab vedotin
Clinical Study IdentifierNCT01969643
SponsorSeagen Inc.
Last Modified on11 June 2021

Eligibility

Yes No Not Sure

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
Part F: All of the following
Triple negative breast cancer
Measurable disease
No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
Eastern Cooperative Oncology Group performance status 0 or 1
Tumor tissue PD-L1 expression CPS <10 expression
Combination Arm: adequate heart function
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

Exclusion Criteria

Pre-existing neuropathy Grade 2 or higher
Combination Arm: hypersensitivity to trastuzumab
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
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