Last updated on June 2018

Dose Escalation Study of JNJ-63709178 a Humanized CD123 x CD3 DuoBody in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)


Brief description of study

The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.

Detailed Study Description

This is first-in-human (FIH) Phase 1, open-label (identity of assigned study drug will be known), multicenter, dose escalation study with dose expansion to identify the RP2D and to evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-63709178 in adult subjects with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for or have exhausted standard therapeutic options. The study is divided into 3 periods: a Screening Phase (within 28 days before the first dose of study drug), a Treatment Phase (first dose of study drug until the last dose of study drug) and a Post-treatment Follow-up Phase (up to the end of study participation or end of study). Subjects' safety will be monitored throughout the study.

Clinical Study Identifier: NCT02715011

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University of Maryland
Baltimore, MD United States
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Barbara Ann Karmanos Cancer Institute
Detroit, MI United States
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Hackensack University Medical Center
Hackensack, NJ United States
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Weill Cornell Medical College / New York Presbyterian Hospital
New York, NY United States
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Memorial Sloan Kettering Cancer Center
New York, NY United States
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University of Rochester
Rochester, NY United States
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Levine Cancer Institute, Carolinas HealthCare System
Charlotte, NC United States
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University of Pennsylvania
Philadelphia, PA United States
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University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Sarah Cannon Research Institute
Nashville, TN United States
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University of Texas, MD Anderson Cancer Center
Houston, TX United States
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Hosp. Univ. Vall D Hebron
Barcelona, Spain
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Hosp. Univ. Fund. Jimenez Diaz
Madrid, Spain
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Hosp. Virgen Del Rocio
Sevilla, Spain
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University of Colorado
Aurora, CO United States
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Fox Chase Cancer Center
Philadelphia, PA United States
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