NCT02848248

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	SGN-CD123A	Intravenous infusion in 3-week cycles

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-04-06
• Completion: 2018-04-06
• First posted: 2016-07-28
• Last updated: 2018-05-14

Locations

7 sites across 1 country: United States