A phase 1, open-label, dose-escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer.

NOT ENROLLING
Protocol # :
14-306
Conditions
HER2 Positive Breast Neoplasms
Hormone Receptor Positive Breast Neoplasms
Triple Negative Breast Neoplasms
HER2 Mutations Breast Neoplasms
Phase
I
Disease Sites
Breast
Principal Investigator
Lynce, Filipa
Site Research Nurses
Campbell, Margaret
Caradonna, Lisa
Casella, Allison
Germon, Victoria
Huff, Kimberly
Kasparian, Elizabeth
LaPointe, Janet
Lehnus, Jaclyn
Macauley, Colleen
Marchetti, Kelly
Morse, Linda, K.
O'Driscoll, Mary
O'Neil, Kelly
Roche, Kathleen, A.
Rutter, Morgan
St Amand, Myra, W.
Tiani, Elizabeth

Trial Description

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.

Eligibility Requirements

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

- 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

Exclusion Criteria:

- 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

14-306