Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB160058 · 2 trials · 2 indications
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Number of participants with TEAEs leading to dose modification or discontinuation.
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
INCB160058 concentration in plasma.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation - with MF, PV or ET | EXPERIMENTAL | INCB160058 will be administered at a protocol defined starting regimen to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF), polycythemia vera (PV) or essential thrombocythemia (ET) will enroll in this group. |
| Part 1 Dose Escalation - with MF SubOpt R | EXPERIMENTAL | INCB160058 will be administered at a protocol defined starting regimen and will allow for the evaluation of INCB160058 in combination with a standard disease-directed therapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group. |
| Part 2 Dose Expansion - with MF, PV or ET | EXPERIMENTAL | INCB160058 will be administered at the RDE(s) identified during Part 1. Participants with MF, PV or ET will enroll in this group. |
| Part 2 Dose Expansion - with MF SubOpt R | EXPERIMENTAL | INCB160058 will be administered as an add-on therapy in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. Participants with myelofibrosis (MF), suboptimal response to a standard disease-directed therapy (SubOpt R) will enroll in this group. |
| Cohort 1: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 2: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 3: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 4: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 5: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 6: Dose Treatment A | EXPERIMENTAL | INCB160058 will be administered at protocol defined dose after an overnight fast. |
| Cohort 6: Dose Treatment B | EXPERIMENTAL | INCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal. |
| Cohort 7: Dose | EXPERIMENTAL | INCB160058 and esomeprazole will be administered at protocol defined schedule and dose. |
| Cohort 8: Dose | EXPERIMENTAL | INCB160058 will be administered at protocol defined dose after an overnight fast. |
| Cohort 9: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 10: Dose Treatment A | EXPERIMENTAL | INCB160058 will be administered at protocol defined dose after an overnight fast. |
| Cohort 10: Dose Treatment B | EXPERIMENTAL | INCB160058 will be administered at protocol defined dose after a high-fat, high-calorie meal. |
| Cohort 11: Dose | EXPERIMENTAL | INCB160058 and esomeprazole will be administered at protocol defined schedule and dose. |
| Cohort 12: Dose | EXPERIMENTAL | INCB160058 and famotidine will be administered at protocol defined schedule and dose. |
| Cohort 13: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Cohort 14: Dose | EXPERIMENTAL | INCB160058 and famotidine will be administered at protocol defined schedule and dose. |
| Cohort 15: Dose | EXPERIMENTAL | INCB160058 or placebo will be administered at protocol defined dose after an overnight fast. |
| Name | Type | Description |
|---|---|---|
| INCB160058 | DRUG | Oral; Tablet |
| Standard disease-directed therapy | DRUG | A standard disease-directed therapy will be administered according to Prescribing Information/SmPC. |
| Placebo | DRUG | Oral; Tablet |
| Esomeprazole | DRUG | Oral; Delayed-release capsule or tablet |
| Famotidine | DRUG | Oral; Tablet |
Inclusion Criteria: * Age ≥ 18 years * MF: * Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly, and for the monotherapy cohort, participants must have been previously treated with at least 1 JAK inhibitor for ≥ 12 weeks ...
INCB160058 is an investigational small molecule being studied for use in healthy participants and in patients with myeloproliferative neoplasms (MPNs). It is currently in Phase 1 clinical development, with trials evaluating its safety, tolerability, and pharmacokinetics when administered orally.
INCB160058 targets the JAK2V617F mutation, a specific genetic alteration associated with myeloproliferative neoplasms. By targeting this mutated kinase, the drug is designed to interfere with the signaling pathways that drive abnormal blood cell production in these conditions.
INCB160058 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability in healthy participants and in patients with myeloproliferative neoplasms.
INCB160058 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing early-stage clinical trials to assess its safety, tolerability, and pharmacokinetics in humans.
INCB160058 is being evaluated in two Phase 1 clinical trials. NCT06213818 is a completed study in healthy adult participants in Australia, with 137 enrolled. NCT06313593 is an active, not recruiting study in patients with myeloproliferative neoplasms across multiple countries, with 37 enrolled.
No alternative names for INCB160058 have been disclosed. The drug is identified solely by its development code INCB160058, and no other names or aliases are currently associated with it in clinical trial registries.