Study of IMC-EB10 in Participant With Leukemia
Condition: Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid
Intervention: IMC-EB10
Intervention description: Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AML; Leukemia; Acute Myeloid Leukemia; Antibodies, Monoclonal

Summary:

      The purpose of this study is to determine if IMC-EB10 is safe for participants with leukemia,
      and also to determine the best dose of IMC-EB10 to give to participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has acute myeloid leukemia in the bone marrow or blood that has
             relapsed with or without a prior complete remission

          2. The participant is not regarded to be a candidate for a potentially curative, higher
             priority treatment for acute myeloid leukemia

          3. The participant 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 participant 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 participant has an Eastern Cooperative Oncology Group (ECOG)performance status of
             0, 1, or 2 at study entry.

          6. The participant is age 18 years or older

          7. The participant has a life expectancy of >3 months

          8. The participant has adequate liver and kidney function, as defined in the entry
             criteria

          9. The participant is using an effective contraception (per the institutional standard),
             if procreative potential exists

         10. The participant is able to give written informed consent

         11. The participant is willing and able to comply with study procedures, scheduled visits,
             and treatment plans

        Exclusion Criteria:

          1. The participant has had prior allogenic or autologous stem cell transplant within <3
             months of the first infusion of IMC-EB10

          2. The participant has had an organ transplant (nonhematologic) within 3 years of study
             entry

          3. The participant has active central nervous system leukemia

          4. The participant has extramedullary disease without peripheral/and or bone marrow
             involvement

          5. The participant is disease-free from a previous or concurrent malignancy for a period
             ≤ 1 year. A participant who has basal cell carcinoma or carcinoma in situ of the
             cervix will not be excluded from the study

          6. The participant is currently receiving antileukemia therapy. Concurrent treatment with
             hydroxyurea is permitted

          7. The participant has uncontrolled intercurrent illness as specified in the study entry
             criteria

          8. The participant is receiving chronic steroid or other immunosuppressive medications.
             Occasional use of steroid-containing medications for, for example (e.g.), asthma
             exacerbation or for skin lesions, is permitted

          9. The participant is receiving full-dose heparin (including low molecular weight
             heparin) or warfarin. [The participant is permitted to use low-dose warfarin to
             maintain patency of preexisting, permanent, indwelling intravenous (I.V.) catheters.]

         10. The participant is pregnant (confirmed by urine or serum pregnancy test) or breast
             feeding

         11. The participant has received treatment with monoclonal antibodies within 6 weeks prior
             to first infusion of IMC-EB10

         12. The participant has a history of clinically significant allergic reactions to
             monoclonal antibodies or other therapeutic proteins