Safety Study of the Drug MM-151 in Patients With Advanced Solid Tumors Resisting Ordinary Treatment

This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3"
design exploring weekly, bi-weekly, and tri-weekly dosing schedules. Successive MM-151
monotherapy cohorts of three or more patients will be treated at escalating doses until a
maximum tolerated dose is identified, and subsequently in combination with irinotecan. The
study consists of three parts as follows: MM-151 monotherapy dose escalation (Part 1); MM-151
monotherapy expansion cohort in cetuximab-refractory colorectal cancer (Part 2); MM-151 +
irinotecan dose escalation (Part 3). It is expected that approximately 4 study sites will
participate.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed advanced malignant solid
tumor that has recurred or progressed following standard therapy, or that has 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 of 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-151 (an effective form of
contraception is an oral contraceptive or a double barrier method)

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