Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCA036978 · 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 AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Dose Escalation | EXPERIMENTAL | INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s). |
| Part 1b: Dose Escalation | EXPERIMENTAL | INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s). |
| Part 2a: Dose Expansion | EXPERIMENTAL | INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1 |
| Part 2b: Dose Expansion | EXPERIMENTAL | INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1. |
| Name | Type | Description |
|---|---|---|
| INCA036978 | DRUG | INCA036978 will be administered at protocol defined dose. |
| Standard disease-directed therapy | DRUG | A standard disease-directed therapy will be administered according to Prescribing Information/SmPC. |
Inclusion Criteria: * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease). * Participants with MF, PV and ET as defined in the protocol. Exclusion Criteria: * Presence of any hematological malignancy other...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
INCA036978 is an investigational small molecule being developed for the treatment of myeloproliferative neoplasms, a group of blood cancers. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
INCA036978 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting a Phase 1 clinical trial of the drug in patients with myeloproliferative neoplasms.
INCA036978 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants with myeloproliferative neoplasms.
INCA036978 is being studied in a Phase 1 clinical trial with the identifier NCT07441694. This trial is recruiting approximately 218 participants with myeloproliferative neoplasms across multiple countries, including the United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, South Korea, Spain, and the United Kingdom.
INCA036978 is a small molecule therapeutic. Its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential to treat myeloproliferative neoplasms, a group of disorders characterized by the overproduction of blood cells in the bone marrow.