Clinical trial · Interventional
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Business Decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors and Hematologic Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| all-trans retinoic acid (ATRA) | Drug | Tretinoin | ALIAS |
| azacitidine | Drug | Azacitidine | ALIAS |
| INCB059872 | Drug | — | UNRESOLVED |
| nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- INCB059872
- interventionNames
- Drug: INCB059872
- type
- EXPERIMENTAL
- label
- INCB059872 in combination with other therapies
- description
- 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).
- interventionNames
- Drug: INCB059872
- Drug: all-trans retinoic acid (ATRA)
- Drug: azacitidine
- Drug: nivolumab
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available