MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: MM-111 + Herceptin
Intervention description: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
Intervention MeSH terms: Trastuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2/HER3; Bispecific Antibody; Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; HER2 Positive Breast Cancer; Trastuzumab; Herceptin

Summary:

      This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed advanced breast cancer
             that is amplified for HER2, based on archived tumor biopsy (IHC 2+ or greater)

          -  Patients must have histologically or cytologically confirmed advanced breast cancer
             that is heregulin positive based on fresh tumor tissue biopsy

          -  The patient's cancer must have recurred, progressed or not responded to standard
             chemotherapy or other standard treatment. Prior therapies may include but are not
             limited to Herceptin, Tykerb (lapatinib), anthracyclines, and taxanes

          -  Patients must be ≥ 18 years of age

          -  Patients or their legal representatives must be able to understand and sign an
             informed consent

          -  Patients may have measurable (per RECIST 1.1) or non-measurable tumor(s) (for Phase 1)

          -  Patients should have ECOG Performance Score (PS) 0, 1 or 2 (for Phase 1).

          -  Patients should have a life expectancy of at least 12 weeks

          -  Patients must have adequate bone marrow reserves

          -  Patients must have adequate hepatic function

          -  Patients must have adequate renal function

          -  Patients must be recovered from the effects of any prior surgery, radiotherapy or
             other antineoplastic therapy.

          -  Women of childbearing potential as well as fertile men and their partners must agree
             to abstain from sexual intercourse or to use an effective form of contraception during
             the study and for 90 days following the last dose of MM-111.

        Exclusion Criteria:

          -  Patients who are pregnant or lactating

          -  Patients with an active infection or with an unexplained fever > 38.5°C (101.3° F)
             during screening visits or on the first scheduled day of dosing.

          -  Patients with untreated and/or symptomatic metastatic CNS malignancies.

          -  Patients with known hypersensitivity to any of the components of MM-111 or who have
             had hypersensitivity reactions to fully human monoclonal antibodies, including
             Herceptin.

          -  Patients who have received other recent antitumor therapy including:

               -  Treatment with Herceptin within the 28 days prior to the first scheduled day of
                  dosing with MM-111

               -  Investigational therapy administered within the 28 days prior to the first
                  scheduled day of dosing MM-111 (Dosing in less than 28 days' since receiving
                  investigational therapy is acceptable once a time interval equal to at least five
                  half-lives of the investigational agent has passed.)

               -  Any standard chemotherapy, Tykerb (lapatinib) or radiation within 14 days (and
                  having passed the time of any actual or anticipated toxicities) prior to the
                  first scheduled dose of MM-111

          -  Patients who have previously received MM-111

          -  Patients with NYHA Class III or IV congestive heart failure or LVEF < 50%

          -  Patients with a history of allogeneic transplant

          -  Patients with known HIV, hepatitis B or C (if patients have previously been treated
             for hepatitis C and have undetectable viral loads, they can be considered eligible for
             the trial)

          -  Patients with any other medical or psychological condition deemed by the Investigator
             to be likely to interfere with a patient's ability to sign informed consent, cooperate
             and participate in the study, or interfere with the interpretation of the results