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.
Checked against the public recordLast updated Nov 4, 2025 · Source: ClinicalTrials.gov
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
Inclusion Criteria: * 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. Exclusion Criteria: * 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.