Study of EB10 in Patients With Leukemia

The purpose of this study is to define the maximum tolerated dose (MTD) and the
pharmacokinetic (PK) profile of the anti-FLT3 monoclonal antibody IMC-EB10, administered
weekly in patients with AML who have failed to achieve complete remission to a standard
induction regimen, relapsed after response to previous antileukemia therapy, or are not
eligible for potentially curative or approved salvage options.

Inclusion Criteria:

1. The patient has acute myeloid leukemia in the bone marrow or blood that has relapsed
with or without a prior complete remission

2. The patient is not regarded to be a candidate for a potentially curative, higher
priority treatment for acute myeloid leukemia

3. The patient has resolution of all clinically significant toxic effects of any prior
antitumor therapy and any other study-specific clinical or laboratory parameter
specified in the entry criteria

4. The patient has not had major surgery, an open biopsy, a significant injury, and/or
prior antitumor therapy (except antileukemia therapy) within 21 days prior to the
first infusion of IMC-EB10

5. The patient has a performance status of 0, 1, or 2 at study entry.

6. The patient is age 18 years or older

7. The patient has a life expectancy of > 3 months

8. The patient has adequate liver and kidney function, as defined in the entry criteria

9. The patient is using an effective contraception (per the institutional standard), if
procreative potential exists

10. The patient is able to give written informed consent

11. The patient is willing and able to comply with study procedures, scheduled visits, and
treatment plans

Exclusion Criteria:

1. The patient has had prior allogenic or autologous stem cell transplant within < 3
months of the first infusion of IMC-EB10

2. The patient has had an organ transplant (nonhematologic) within 3 years of study entry

3. The patient has active central nervous system leukemia

4. The patient has extramedullary disease without peripheral/and or bone marrow
involvement

5. The patient is disease-free from a previous or concurrent malignancy for a period ≤ 1
year. A patient who has basal cell carcinoma or carcinoma in situ of the cervix will
not be excluded from the study

6. The patient is currently receiving antileukemia therapy. Concurrent treatment with
hydroxyurea is permitted

7. The patient has uncontrolled intercurrent illness as specified in the study entry
criteria

8. The patient is receiving chronic steroid or other immunosuppressive medications.
Occasional use of steroid-containing medications, eg, for asthma exacerbation or for
skin lesions, is permitted

9. The patient is receiving full-dose heparin (including low molecular weight heparin) or
warfarin. (The patient is permitted to use low-dose warfarin to maintain patency of
preexisting, permanent, indwelling I.V. catheters.)

10. The patient is pregnant (confirmed by urine or serum pregnancy test) or breast feeding

11. The patient has received treatment with monoclonal antibodies within 6 weeks prior to
first infusion of IMC-EB10

12. The patient has a history of clinically significant allergic reactions to monoclonal
antibodies or other therapeutic proteins