A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available

The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD)
of the anti-IGF-IR monoclonal antibody IMC-A12 administered weekly in participants with
advanced solid tumors who no longer respond to standard therapy or for whom no standard
therapy is available

Inclusion Criteria:

- Histopathologically-documented, measurable, advanced primary or recurrent solid tumors
that no longer respond to standard therapy or for which no standard therapy is
available.

- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study
entry

- Able to provide written informed consent

- Life expectancy of >3 months

- Adequate hematologic functions, as defined by: absolute neutrophil count (ANC)
≥1500/cubic millimeter (mm³), hemoglobin level ≥10 grams/deciliter (gm/dL), platelet
count ≥100,000/mm³

- Adequate hepatic function, as defined by: total bilirubin level ≤1.5 x the upper limit
of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) levels
≤2.5 x the ULN or ≤5 x the ULN if known liver metastases

- Adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN

- Ejection fraction within the normal institutional limits

- Use of effective contraception per institutional standard, if procreative potential
exists

- At least 28 days must have elapsed from major surgery, prior chemotherapy, prior
treatment with an investigational agent or device, prior radiation therapy (palliative
radiation therapy is allowed), an open biopsy, or a significant traumatic injury to
allow for adequate recovery. Ongoing side effects due to these agents must be ≤Grade 2
prior to entering the study.

- At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal
antibody [not targeting the insulin-like growth factor receptor (IGFR)] therapy to
allow for adequate recovery. Ongoing side effects due to these agents must be ≤Grade 2
prior to entering the study.

- Accessible for treatment and follow-up. Participants enrolled in this trial must be
treated at the participating center.

Exclusion Criteria:

- Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ
of the cervix. Participants with a previous malignancy but without evidence of disease
for ≥3 years will be allowed to enter the trial.

- Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection requiring parenteral antibiotics, symptomatic congestive heart failure,
unstable angina pectoris, angioplasty, stenting or myocardial infarction within 6
months, uncontrolled hypertension, clinically significant cardiac arrhythmia,
psychiatric illness/social situations that would compromise participant safety or
limit compliance with study requirements, participants with symptomatic brain
metastases

- Serious or nonhealing active wound, ulcer or bone fracture

- Know human immunodeficiency virus (HIV)-positive

- History of hemorrhagic or thrombotic disorder within 9 months

- Proteinuria ≥1+ by routine urinalysis (participants with a protein value of ≤500
milligrams (mg) confirmed by a 24-hour urine collection are eligible)

- Pregnant [confirmed by serum beta human chorionic gonadotropin (βHCG)] or breast
feeding

- History of prior treatment with other agents specifically targeting IGFRs

- Known diabetes

- Inability or unwillingness to interrupt steroidal or hormonal therapy for the duration
of treatment with IMC-A12

- Positive anti-IMC-A12 antibody response

- History of allergic reactions to monoclonal antibodies or other therapeutic proteins

- Employees of the investigator or study center with direct involvement in this study or
other studies under the direction of the investigator or study center, as well as
family members of the employees.