Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB160058 · 1 trial · 1 indication
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.
| 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. |
| 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. |
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 ...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
INCB160058 is an investigational small molecule being developed by Incyte Corporation for myeloproliferative neoplasms, a group of blood cancers. It is in Phase 1 clinical development and is designed to target the JAK2V617F mutation. It has not been approved by the FDA.
INCB160058 is being studied for the treatment of myeloproliferative neoplasms, a group of bone marrow disorders in which the body produces too many blood cells. It is an investigational therapy in Phase 1 testing and is not yet approved for any indication.
INCB160058 targets JAK2V617F, a mutated form of the JAK2 kinase that is commonly found in myeloproliferative neoplasms. By acting on this specific mutant protein, the small molecule is designed to address the driver of these blood cancers.
INCB160058 is being developed by Incyte Corporation, a biopharmaceutical company that trades on the Nasdaq under the ticker symbol INCY. Incyte is the sponsor of the clinical program evaluating the drug in myeloproliferative neoplasms.
INCB160058 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program is evaluating its safety and tolerability in participants with myeloproliferative neoplasms.
INCB160058 is being evaluated in the Phase 1 trial NCT06313593, titled a study to evaluate the safety and tolerability of INCB160058 in participants with myeloproliferative neoplasms. The trial has enrolled 37 participants and is active but not recruiting, with sites in the United States, Canada, and several European countries.