A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Overview
- Phase
- Phase 1
- Intervention
- SGN-CD123A
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Seagen Inc.
- Enrollment
- 17
- Locations
- 7
- Primary Endpoint
- Type, incidence, severity, seriousness, and relatedness of adverse events
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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: 1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A 2. 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
SGN-CD123A
SGN-CD123A every 3 weeks
Intervention: SGN-CD123A
Outcomes
Primary Outcomes
Type, incidence, severity, seriousness, and relatedness of adverse events
Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Type, incidence, and severity of laboratory abnormalities
Time Frame: Through 1 month following last dose, or end-of-treatment visit whichever is later
Incidence of dose-limiting toxicity
Time Frame: First cycle of treatment, 3 weeks
Secondary Outcomes
- 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)