Adults 3 to 21, any sex, with Glioblastoma Multiforme or Anaplastic Astrocytoma. 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.
Number of Patients Who Experienced Dose-limiting Toxicities (DLTs)Primary· Approximately 28 days
All subjects evaluable for dose-finding were classified as having DLT or not having DLT, and the number of subjects having DLT was reported. Any INCB7839-related adverse events during the first course of treatment that led to dose reduction, permanent cessation of therapy, or a delay in treatment of \>7 days were considered DLTs. Hematologic DLTs included any grade 4 hematologic toxicity except lymphopenia; grade 3 neutropenia with fever; or requiring a platelet transfusion on 2 separate days during a single course. Non-hematologic DLTs included any grade 4 non-hematologic toxicity; any grade
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
3
Maximum Tolerated Dose (MTD) and/or Recommend Phase II Dose (RP2D) of INCB7839Primary· Approximately 28 days
A design similar to the Rolling-6 design was used and 6 slots were initially opened on the starting dose level (dose level 1, INCB7839 120 mg/m\^2/dose BID). If no more than one dose-limiting toxicity (DLT) was observed in these 6 subjects, we would expand this cohort to at least 12 patients for additional safety and pharmacokinetic information. If more than 3 DLTs were observed in 12 subjects at dose level 1, then the initially identified maximum tolerated dose based on 6 subjects would be considered unsafe and de-escalation to a lower dose level (INCB7839 80 mg/m\^2/dose BID) would be consid
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
NA
Area Under the Curve (AUC) of INCB7839Primary· Up to 3 days after the start of treatment
Pharmacokinetic (PK) studies were performed after an oral INCB7839 dose on days 1, 2, and 3 of Course 1. Beginning day 1 of Course 1, INCB7839 serial blood PK samples were drawn pre-dose and at approximately 1, 4, 8, 24, and 48 hours after the first dose. Time points at which data were collected to create the curve were 0, 1, 4, 8, 24 and 48 hours post-dose. The area under the curve (AUC) was estimated using a noncompartmental method.
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
3852
1820 – 8638
Maximum Concentration [Cmax] of INCB7839Primary· Up to 3 days after the start of treatment
Pharmacokinetic (PK) studies were performed after an oral INCB7839 dose on days 1, 2, and 3 of Course 1. Beginning day 1 of Course 1, INCB7839 serial blood PK samples were drawn pre-dose and at approximately 1, 4, 8, 24, and 48 hours after the first dose. Time points at which data were collected were 0, 1, 4, 8, 24 and 48 hours post-dose. The maximum concentration (Cmax) was estimated using a noncompartmental method.
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
558
130 – 1262
Apparent Oral Clearance [CL/F] of INCB7839Primary· Up to 3 days after the start of treatment
Pharmacokinetic (PK) studies were performed after an oral INCB7839 dose on days 1, 2, and 3 of Course 1. Beginning day 1 of Course 1, INCB7839 serial blood PK samples were drawn pre-dose and at approximately 1, 4, 8, 24, and 48 hours after the first dose. Time points at which data were collected were 0, 1, 4, 8, 24 and 48 hours post-dose. Clearance (CL/F) was estimated using a noncompartmental method.
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
34.6
18.5 – 68.5
Time to Reach Maximum Concentration [Tmax] of INCB7839Primary· Up to 3 days after the start of treatment
Pharmacokinetic (PK) studies were performed after an oral INCB7839 dose on days 1, 2, and 3 of Course 1. Beginning day 1 of Course 1, INCB7839 serial blood PK samples were drawn pre-dose and at approximately 1, 4, 8, 24, and 48 hours after the first dose. Time points at which data were collected were 0, 1, 4, 8, 24 and 48 hours post-dose. The time to reach maximum concentration (Tmax) was estimated using a noncompartmental method.
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
4.0
3.9 – 8.4
Percent Probability of Progression-free SurvivalSecondary· 3 months from first dose of INCB7839
Progression-free survival (PFS) was defined as the time interval from date of treatment start to date of first event (progressive disease or death due to any cause) for patients with events, or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier and reported with a 95% confidence interval. We had planned to report the 2-year PFS estimate, but the 2-year estimate was not defined as most subjects progressed prior to 2 years. The 3-month PFS estimate was reported. All subjects are off study and data collection has concluded for this ou
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
18.18
0 – 40.97
Percent Probability of Overall SurvivalSecondary· 3 months from first dose of INCB7839
Overall survival (OS) was defined as the time interval from date of treatment initiation to date of death due to any cause or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier and reported with a 95% confidence interval. All subjects are off study and data collection has concluded for this outcome measure.
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
53.69
17.02 – 90.36
ADAM10 Inhibition of HER2Secondary· Baseline and Day 14 of Course 1
HER2 extracellular domain (ECD) in serum will be reported.
Baseline
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
16.66
4.24 – 37.26
Course 1, Day 14
Group
Value
95% CI
Dose Level 1 (120 mg/m^2/Dose)
17.55
4.64 – 114.00
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected while participants were on protocol therapy and up to 6 months while in follow-up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a multicenter phase 1 trial of INCB7839 for children with recurrent or progressive high-grade gliomas, including, but not limited to, diffuse intrinsic pontine glioma (DIPG) and other diffuse midline gliomas (DMGs), after upfront therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Pediatric Brain Tumor Consortium
Last refreshed: 5 January 2026
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/NCT04295759.