An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Solid Tumors and Hematologic Malignancy

In brief

This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.

Key facts

Study ID

NCT02712905

Run by

Incyte Corporation

People needed

116

Starts

2016-05-05

Expected to finish

2022-04-14

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects, age 18 years or older.
• Presence of measurable disease that has been confirmed by histology or cytology.
• Must not be a candidate for potentially curative therapy or standard-of-care approved therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

You may not qualify if…

• Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
• Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
• Laboratory and medical history parameters outside Protocol-defined range.
• Known additional malignancy that is progressing or requires active treatment.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Center for Research, Inc. — Kansas City, Kansas, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Columbia University — New York, New York, United States
• Oregon Health Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Institut Jules Bordet — Brussels, Belgium
• Netherland Cancer Institute — Amsterdam, Netherlands
• VU Medical Center — Amsterdam, Netherlands
• Erasmus MC — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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