Clinical Trials /

A Safety Study of SGN-LIV1A in Breast Cancer Patients

NCT01969643

Description:

This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Safety Study of <span class="go-doc-concept go-doc-intervention">SGN-LIV1A</span> in <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Patients

Title

  • Brief Title: A Safety Study of SGN-LIV1A in Breast Cancer Patients
  • Official Title: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer
  • Clinical Trial IDs

    NCT ID: NCT01969643

    ORG ID: SGNLVA-001

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    SGN-LIV1A SGN-LIV1A

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    SGN-LIV1A Experimental SGN-LIV1A every 3 weeks by intravenous infusion SGN-LIV1A

    Eligibility Criteria

    Inclusion 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 archival or newly
    obtained tumor tissue biopsy

    - Measurable disease

    - Eastern Cooperative Oncology Group performance status 0 or 1

    Exclusion Criteria:

    - 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    Incidence of adverse events

    Incidence of laboratory abnormalities

    Secondary Outcome Measures

    Blood concentrations of SGN-LIV1A and metabolites

    Incidence of antitherapeutic antibodies

    Objective response rate

    Duration of response

    Progression-free survival

    Progression-free survival relative to prior therapy

    Trial Keywords

    Breast cancer

    Monomethyl auristatin E

    Antibody-drug conjugate

    Drug therapy

    Metastatic

    LIV-1 protein, human