A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

Detailed Description
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This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts: Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles. After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A. For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.

Official Title
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A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: SGN-CD123A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens Patients may be eligible after only 1 previous regimen if in a high risk category Adequate baseline renal and hepatic function Eastern Cooperative Oncology Group Status of 0 or 1 CD123-detectable leukemia Exclusion Criteria: Cerebral/meningeal disease related to underlying malignancy Promyelocytic leukemia History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide <50% predicted Prior hematopoietic stem cell transplant Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine) Cardio or cerebral vascular event within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGN-CD123A<br>SGN-CD123A every 3 weeks | Drug: SGN-CD123A<br>* Intravenous infusion in 3-week cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, incidence, severity, seriousness, and relatedness of adverse events |  | Through 1 month following last dose, or end-of-treatment visit whichever is later | 
| Type, incidence, and severity of laboratory abnormalities |  | Through 1 month following last dose, or end-of-treatment visit whichever is later | 
| Incidence of dose-limiting toxicity |  | First cycle of treatment, 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood concentrations of SGN-CD123A, total antibodies, and metabolites |  | Through 1 month following last dose, or end-of-treatment visit whichever is later | 
| Incidence of antitherapeutic antibodies |  | Through 1 month following last dose, or end-of-treatment visit whichever is later | 
| Rate of remission |  | Through 1 month following last dose, or end-of-treatment visit whichever is later | 
| Duration of complete remission |  | Up to approximately 1 year | 
| Leukemia-free survival |  | Up to approximately 1 year | 
| Overall survival |  | Up to approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia, Antibody-Drug Conjugate, CD123 Antigen, Drug Therapy, AML, Leukemia, Myeloid, Acute