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

Seagen

Status and phase: Terminated; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: SGN-CD123A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02848248

SGN123-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

SGN-CD123A

Experimental group

Description:

SGN-CD123A every 3 weeks

Treatment:

Drug: SGN-CD123A