A Five-Tier, Open-Label Study of IMC-A12 in Advanced Sarcoma

The purpose of this study is to determine the progression-free survival (PFS) rate assessed
12 weeks after the initiation of IMC-A12 monotherapy, administered every 2 weeks to
participants with previously-treated, advanced or metastatic soft tissue and Ewing's
sarcoma/PNET.

Inclusion:

- Histologically or cytologically-confirmed sarcoma of one of the following histologies:
(1) Ewing's sarcoma / PNET; (2) rhabdomyosarcoma; (3) leiomyosarcoma; (4) adipocytic
sarcoma; or (5) synovial sarcoma

- Has measurable disease, at least one lesion ≥ 2 centimeters (cm) on conventional
measurement techniques or ≥ 1 cm on spiral computed tomography (CT) scan

- Has at least one measurable lesion located outside of a previously irradiated area

- Has radiographic documentation of disease progression within 6 months prior to study
entry

- Has relapsed, refractory, and/or metastatic disease, incurable by surgery,
radiotherapy, or other conventional systemic therapy

- Been considered ineligible for systemic chemotherapy or received at least one previous
regimen for relapsed, refractory, and/or metastatic disease

- Adequate hematologic function

- Has adequate hepatic function

- Has adequate coagulation function

- Has adequate renal function

- Has fasting serum glucose < 120 milligrams per deciliter (mg/dL) or below the upper
limit of normal (ULN)

- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation

Exclusion:

- Has uncontrolled brain or leptomeningeal metastases

- Not recovered to grade ≤ 1 from adverse events due to agents administered more than 3
weeks prior to study entry

- Is receiving any other investigational agent(s)

- Major surgery, hormonal therapy (other than replacement), chemotherapy, radiotherapy,
or any form of investigational therapy within 3 weeks prior to enrollment

- History of treatment with other agents targeting the insulin-like growth factor-I
receptor (IGF-IR)

- History of allergic reactions attributed to compounds of chemical or biologic
composition similar to that of IMC-A12

- Has poorly controlled diabetes mellitus

- Is receiving therapy with immunosuppressive agents

- Is pregnant or breastfeeding