Clinical Trial: PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies

Brief Summary: The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Detailed Summary:
Sponsor: Xencor, Inc.

Current Primary Outcome:

• Identification of the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) for first and subsequent infusions [ Time Frame: Baseline Day 1 through Day 56 ]
• Safety and tolerability as assessed by AEs, vital signs, physical exam findings, clinical laboratory safety assessments, and electrocardiogram (ECG) parameters, and incidence of treatment-emergent AEs [ Time Frame: Baseline Day 1 through Day 56 ]

Original Primary Outcome:

• Number of patients experiencing an adverse event [ Time Frame: Baseline Day 1 up to Day 43 ]
  As assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03
• Percentage of patients experiencing an adverse event [ Time Frame: Baseline Day 1 up to Day 43 ]
  As assessed by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Xencor, Inc.

Dates:
Date Received: March 31, 2016
Date Started: August 2016
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016