Clinical Trials /

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

NCT01997333

Description:

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Glembatumumab Vedotin</span> (<span class="go-doc-concept go-doc-intervention">CDX</span>-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
  • Official Title: A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)
  • Clinical Trial IDs

    NCT ID: NCT01997333

    ORG ID: CDX011-04

    Trial Conditions

    Metastatic gpNMB Over-expressing Triple Negative Breast Cancer.

    Trial Interventions

    Drug Synonyms Arms
    CDX-011 Drug: CDX-011
    Capecitabine Capecitabine

    Trial Purpose

    The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an
    antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative
    Breast Cancer (TNBC; i.e., tumors lacking expression of estrogen, progesterone and HER2
    receptors), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which
    CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment
    in this patient population.

    Detailed Description

    CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can
    kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein
    called glycoprotein NMB (gpNMB) that is expressed on the cancer cell. The MMAE is then
    released inside of the cell, where it interferes with cell growth and may lead to cell
    death.

    This study will examine the effectiveness and safety of CDX-011 in patients with advanced
    TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment
    with capecitabine.

    Eligible patients who enroll in the study will be randomly assigned (by chance) to receive
    treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will
    receive CDX-011 and one will receive treatment with capecitabine. All patients enrolled in
    the study will be closely monitored to determine if their cancer is responding to treatment
    and for any side effects that may occur.

    Trial Arms

    Name Type Description Interventions
    Capecitabine Active Comparator Capecitabine will be administered on Days 1 through 14 of each 21 day cycle. Capecitabine
    Drug: CDX-011 Experimental CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-011

    Eligibility Criteria

    Inclusion Criteria:

    Among other criteria, patients must meet all of the following conditions to be eligible
    for the study:

    1. Diagnosed with metastatic (i.e., cancer that has spread) triple negative (does not
    have hormone receptors ER or PR or HER2) breast cancer.

    2. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting
    a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease
    setting to a central laboratory for analysis.

    3. Received no more than two prior chemotherapy treatments for advanced (locally
    advanced/recurrent or metastatic) breast cancer.

    4. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin
    or Doxil) if clinically indicated and a taxane (eg: Taxol).

    5. ECOG performance status of 0 - 1.

    6. Adequate bone marrow, liver and renal function.

    Exclusion:

    Among other criteria, patients who meet any of the following conditions are NOT eligible
    for the study:

    1. Progression/recurrence of breast cancer during or within 3 months of completion of
    neoadjuvant or adjuvant chemotherapy.

    2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are
    moderate (Grade 2) or worse in severity.

    3. Known brain metastases, unless previously treated and asymptomatic for 2 months and
    not progressive in size or number for 2 months.

    4. Significant cardiovascular disease.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    Objective Response Rate (ORR)

    Duration of Response (DOR)

    Overall Survival (OS)

    Adverse Events (AE)

    Pharmacokinetic (PK)

    Trial Keywords

    Metastatic Breast Cancer

    Locally advanced breast cancer

    Breast cancer

    Triple negative

    Estrogen

    Progesterone

    HER2 receptors

    Targeted treatment for breast cancer

    Antibody-drug-conjugate

    Breast Neoplasms

    CDX-011

    gpNMB

    METRIC

    Glembatumumab vedotin

    Triple Negative Breast Cancer

    TNBC