18 and older, any sex, with Solid Tumors or Advanced Malignancies. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)Primary· From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defi
Phase 2: Objective Response Rate (ORR) in Hematological MalignanciesPrimary· Baseline through end of study (Up to approximately 4.5 years)
ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
Group
Value
95% CI
Phase 2 Cohort I-INCB052793 +Azacytidine (AML)
0
Phase 2 Cohort I-INCB052793 +Azacytidine (MDS)
1
Phase 2 Cohort J-Itacitinib +Azacitidine (AML)
1
Phase 2 Cohort J-Itacitinib +Azacitidine (MDS)
0
Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's AssessmentSecondary· Baseline through end of study (Up to approximately 4.5 years)
Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, M
Group
Value
95% CI
Phase 1a TGA - INCB052793 in Solid Tumors
0
Phase 1a TGB - INCB052793 in Lymphoma
0
Phase 1a TGB - INCB052793 in MDS/MPN
1
Phase 1a TGB - INCB052793 in MM
0
Phase 1b Cohort B - INCB052793 + Dexamethasone in MM
2
Phase 1b Cohort F-INCB052793 +Azacytidine in AML
4
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS
3
Phase 1b Cohort F-INCB052793 +Azacytidine in MDS/MPN
2
Phase 2: Number of Participants With at Least One TEAE and SAESecondary· From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)
An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defi
Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793Secondary· Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793Secondary· Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793Secondary· Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for ItacitinibSecondary· Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
Tmax is the time to maximum (peak) observed plasma drug concentration.
Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for ItacitinibSecondary· Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2
AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
Time frame: From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03906344 — Expanded Access Use of INCB052793 to Treat a Single Patient With Myelofibrosis
· no longer available
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 17 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02265510.