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

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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)

17 participants in 1 patient group

SGN-CD123A
Experimental group
Description:
SGN-CD123A every 3 weeks
Treatment:
Drug: SGN-CD123A

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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