A Study of MM-111 in Patients With Advanced, Refractory Her2 Amplified, Heregulin Positive Cancers
Condition: Her2 Amplified Solid Tumors; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: MM-111
Intervention description: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Her2 amplified solid tumors; Breast Cancer; Her3/ErbB3; Bispecific Antibody

Summary:

      This study is an open-label Phase 1 trial of MM-111.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed advanced cancer that is:

               -  HER2 amplified (IHC 2+ or greater) based on archived tumor evaluation

               -  Heregulin positive based on a study required fresh biopsy sample performed at
                  screening and confirmed by central laboratory

          -  Patients must have blocks of archived formalin-fixed, paraffin-embedded tumor tissue
             available for sectioning and immunohistochemical staining

          -  Patient's cancer must have recurred or progressed following standard therapy, have not
             responded to standard therapy, or for which no standard therapy exists.

          -  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 or non-measurable tumor(s)

          -  Patients should have ECOG Performance Score (PS) 0 or 1

          -  Patients must have adequate bone marrow reserves as evidenced by:

               -  Absolute neutrophil count (ANC) >= 1,500/uL and

               -  Platelet count >= 100,000/uL

               -  Hemoglobin >= 9 g/dL

          -  Patients must have tumor tissue amenable to biopsy

          -  Patients must be willing to undergo biopsy prior to treatment to MM-111

        Exclusion Criteria:

          -  Patients for whom potentially curative antineoplastic therapy is available

          -  Patients who are pregnant or lactating

          -  Patients with an active infection or with an unexplained fever greater than 38.5 C
             during screening visits or on the first scheduled day of dosing. (At the discretion of
             the investigator, patients with tumor fever may be enrolled)

          -  Patients with untreated and/or symptomatic primary or metastatic CNS malignancies
             (patients with CNS metastases who have undergone surgery or radiotherapy, whose
             disease is stable, and who have been on a stable dose of corticosteroids for at least
             2 weeks prior to the first scheduled day of dosing will be eligible for the trial

          -  Patients with known hypersensitivity to any of the components of MM-111 or who have
             had hypersensitivity reactions to fully human monoclonal antibodies (patients with a
             history of hypersensitivity to trastuzumab, a humanized antibody, are not excluded)

          -  Patients with known HIV, hepatitis B or C (if patients have previously been treated
             for C and have undetectable viral loads, they can be considered eligible for the
             trial)