Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB057643 · 2 trials · 8 indications
Defined as maximum observed plasma concentration of INCB057643.
Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.
Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with ruxolitinib.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Treatment A | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 3: Dose Treatment C | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment D | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment E | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Part 1 : INCB057643 Monotherapy | EXPERIMENTAL | INCB057643 dose escalation and dose expansion |
| Part 2 : INCB057643 Combination with Ruxolitinib | EXPERIMENTAL | Combination arm in dose escalation and dose expansion |
| Name | Type | Description |
|---|---|---|
| INCB057643 | DRUG | Tablet |
| Ruxolitinib | DRUG | Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2. |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Aged 18 to 55 years, inclusive, at the time of signing the ICF. * BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI \>...
INCB057643 is an investigational small molecule being studied for use in myelofibrosis and other advanced myeloid neoplasms, including myelodysplastic syndrome, myeloproliferative neoplasms, and related conditions. It is also being evaluated in healthy volunteers for formulation studies. The drug is in Phase 1 clinical development and is not yet approved.
INCB057643 is being developed by Incyte Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol INCY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with myelofibrosis and other myeloid conditions.
INCB057643 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety, tolerability, and pharmacokinetics in patients with myelofibrosis and related myeloid neoplasms, as well as in healthy volunteers.
INCB057643 is being studied in two Phase 1 clinical trials. NCT04279847 is an active, not recruiting study evaluating safety and tolerability in participants with myelofibrosis and other advanced myeloid neoplasms, with an enrollment of 140. NCT06941077 is a completed study assessing the relative bioavailability of new tablet formulations in healthy participants.
No alternative names for INCB057643 have been reported. The drug is identified solely by its code name INCB057643 in clinical trial registrations and is being developed by Incyte Corporation for the treatment of myelofibrosis and other myeloid malignancies.