An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 4, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Incyte Corporation
- Interventions being studied
- Drug: INCB059872; Drug: all-trans retinoic acid (ATRA); Drug: azacitidine; Drug: nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of AlabamaBirmingham, Alabama
- Moores UCSD Cancer CenterLa Jolla, California
- UCLA Medical CenterLos Angeles, California
- Northwestern UniversityChicago, Illinois
- University of Kansas Center for Research, Inc.Kansas City, Kansas
- Roswell Park Cancer InstituteBuffalo, New York
- Columbia UniversityNew York, New York
- Oregon Health Science UniversityPortland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania
- Vanderbilt UniversityNashville, Tennessee
- University of Texas MD Anderson Cancer CenterHouston, Texas
- Institut Jules BordetBrussels
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 4, 2025. Always confirm current availability with the study team.