An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Solid Tumors and Hematologic Malignancy
About this trial
This is an interventional treatment trial for Solid Tumors and Hematologic Malignancy focused on measuring Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), small cell lung cancer (SCLC), myelofibrosis (MF), solid tumor, lysine-specific demethylase 1 (LSD1) inhibitor
Eligibility Criteria
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.
Sites / Locations
- University of Alabama
- Moores UCSD Cancer Center
- UCLA Medical Center
- Northwestern University
- University of Kansas Center for Research, Inc.
- Roswell Park Cancer Institute
- Columbia University
- Oregon Health Science University
- University of Pennsylvania
- Vanderbilt University
- University of Texas MD Anderson Cancer Center
- Institut Jules Bordet
- Netherland Cancer Institute
- VU Medical Center
- Erasmus MC
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
INCB059872
INCB059872 in combination with other therapies
Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups: Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML. Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment. Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s).