Phase I Safety Study of the Drug MM-121 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: MM-121
Intervention description: Dose escalation Frequency - once weekly
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer, solid tumors, oncology, Phase I, ErbB3, HER3; (erbB-3, HER-3)

Summary:

      This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3"
      design to determine maximum tolerated dose/recommended Phase 2 dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed advanced solid tumors
             that have recurred or progressed following standard therapy, or that have not
             responded to standard therapy, or for which there is no standard therapy, or who are
             not candidates for standard therapy

          -  Patients must be > 18 years of age

          -  Patients or their legal representatives must be able to understand and sign an
             informed consent form

          -  Patients must have evaluable or measurable tumor(s)

               -  Patients must be recovered from the effects of any prior surgery, radiotherapy or
                  other antineoplastic therapy. Up to CTCAE Grade 1 is acceptable for patients with
                  known peripheral neuropathy.

               -  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-121
                  (an effective form of contraception is an oral contraceptive or a double barrier
                  method)

        In addition, patients to be enrolled the Expansion Cohort must have/be:

          -  Advanced/metastatic breast cancer with histological/cytological documentation of ER-,
             PR-, Her2/neu non-over-expressing breast cancer (triple negative breast cancer); OR,

          -  Patients must have advanced/metastatic breast cancer with histologically or
             cytologically confirmed ER+ and/or PR+, Her2/neu non-over-expxressing OR,

          -  Patients must have advanced/metastatic histological confirmation of epithelial ovarian
             cancer, fallopian tube cancer or primary peritoneal cancer; OR,

          -  Additional tumor types such as metastatic colorectal, advanced non small cell lung
             cancer, and others may be considered on a per-patient basis

          -  Tumor tissue amenable to biopsy

          -  Platelet counts, partial thromboplastin time (PTT) and international normalized ratio
             (INR) within normal limits.

          -  Willing to undergo tumor biopsy twice (once before and once after treatment with
             MM-121)

          -  Blocks of archived formalin-fixed, paraffin-embedded, unstained tumor tissue available
             for submission. Patients with no available archived tumor tissue available must
             receive Sponsor approval prior to enrollment.

        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 > 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 CNS malignancies (primary or metastatic);
             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

          -  NYHA Class III or IV congestive heart failure or LVEF < 55%

          -  Known HIV, hepatitis B or C (active, previously treated or both)