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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LV Dose Escalation
  • Drug: ladiratuzumab vedotin
    LV will be given into the vein (IV; intravenously)
    Other names:
    • LV
    • SGN-LIV1A
Experimental
LV + Trastuzumab
  • Drug: ladiratuzumab vedotin
    LV will be given into the vein (IV; intravenously)
    Other names:
    • LV
    • SGN-LIV1A
  • Drug: Trastuzumab
    Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
    Other names:
    • Herceptin
Experimental
LV Monotherapy 		LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).
  • Drug: ladiratuzumab vedotin
    LV will be given into the vein (IV; intravenously)
    Other names:
    • LV
    • SGN-LIV1A

More Details

Status
Completed
Sponsor
Seagen Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.