Approval Probability
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ML Risk
INCA035784 · 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 up to 90 days after the last dose of study drug.
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Dose escalation | EXPERIMENTAL | INCA035784 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE\[s\]). Participants with myeloproliferative neoplasm (MPN) will enroll in this group. |
| Part 1b: Dose expansion | EXPERIMENTAL | INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group. |
| Name | Type | Description |
|---|---|---|
| INCA035784 | DRUG | INCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part. |
Inclusion Criteria: * Age 18 years or older at the time of signing the ICF * ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b) * Documented CALR exon-9 mutation * Confirmed diagnosis of MPN according to the 2022 ICC criteria: * DIPSS+...
| 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 |
INCA035784 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 has not been approved by regulatory authorities.
INCA035784 targets mutant calreticulin, or mutCALR, a gene that is implicated in the development of myeloproliferative neoplasms. By targeting this specific genetic alteration, the drug aims to address the underlying cause of the disease.
INCA035784 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 to evaluate the drug in patients with myeloproliferative neoplasms.
INCA035784 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is currently recruiting participants.
INCA035784 is being studied in a Phase 1 clinical trial registered as NCT07008118, titled 'A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms.' The trial is recruiting up to 120 participants across the United States, Australia, Belgium, Germany, and Italy.