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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+...
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 |
INCA035784 is an investigational small molecule drug being developed by Incyte Corporation for myeloproliferative neoplasms, a group of blood cancers. It is designed to target mutCALR, a mutated form of the calreticulin gene. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
INCA035784 is being studied for the treatment of myeloproliferative neoplasms, which are cancers of the blood and bone marrow. It is an investigational therapy and is not yet approved for any indication. The ongoing Phase 1 trial is evaluating its use in adults with these conditions.
INCA035784 targets mutCALR, which is a mutated form of the calreticulin gene. This mutation is found in a subset of patients with myeloproliferative neoplasms. By targeting mutCALR, the drug aims to address the underlying genetic driver of the disease in biomarker-selected patients.
INCA035784 is being developed by Incyte Corporation, a biopharmaceutical company traded on the Nasdaq under the ticker symbol INCY. Incyte is responsible for the clinical development of the drug, including the ongoing Phase 1 study in myeloproliferative neoplasms.
INCA035784 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial is currently recruiting participants and is designed to evaluate the drug in patients with myeloproliferative neoplasms.
INCA035784 is being evaluated in a single Phase 1 clinical trial, NCT07008118, titled A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms. The trial is currently recruiting and plans to enroll 120 participants across the United States, Australia, Belgium, Germany, and Italy.