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Also known as AJ1-11095
LY5830966 · 1 trial · 1 indication
Treatment Emergent AEs will be assessed during routine study visits and compared to Baseline to continuously evaluate safety and tolerability of LY5830966.
Protocol-defined potential DLTs will be assessed by the Safety Review Committee at routine intervals.
Safety evaluations will occur consistently for each patient and across patients to assess MTD or RP3D. See description of safety evaluations described in outcomes 1 and 2 mentioned above.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Dose A of LY5830966 taken orally by participants. |
| Cohort 2 | EXPERIMENTAL | Dose B of LY5830966 taken orally by participants. |
| Cohort 3 | EXPERIMENTAL | Dose C of LY5830966 taken orally by participants. |
| Cohort 4 | EXPERIMENTAL | Dose D of LY5830966 taken orally by participants. |
| Cohort 5 | EXPERIMENTAL | Dose E of LY5830966 taken orally by participants. |
| Dose Expansion Cohort 1 | EXPERIMENTAL | Candidate RP3D of LY5830966 taken orally by participants. |
| Dose Expansion Cohort 2 | EXPERIMENTAL | Alternative candidate RP3D of LY5830966 taken orally by participants. |
| Dose Exploration Cohort 1 | EXPERIMENTAL | Dose F of LY5830966 taken orally by participants |
| Dose Exploration Cohort 2 | EXPERIMENTAL | Dose G of LY5830966 taken orally by participants |
| Dose Exploration Cohort 3 | EXPERIMENTAL | Dose H of LY5830966 taken orally by participants\[ |
| Name | Type | Description |
|---|---|---|
| LY5830966 | DRUG | Type II JAK2 Inhibitor |
Inclusion Criteria: * Diagnosis of PMF, post-PV MF, or post-ET MF. * Dynamic International Prognostic Scoring System (DIPSS) Intermediate-1, Intermediate-2 or High-risk MF with less than or equal to (≤)10% blasts, regardless of JAK2 mutation status. * Estimated spleen volume greater than or equal t...
LY5830966 is an investigational small molecule being developed by Eli Lilly and Company for the treatment of myelofibrosis, a type of bone marrow cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is being studied in patients with primary myelofibrosis and related myelofibrosis subtypes.
LY5830966 is being studied for primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. The Phase 1 trial enrolls patients whose disease has failed prior treatment with a type I JAK2 inhibitor. It is investigational and has not been approved for any indication.
LY5830966 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 clinical program evaluating the small molecule in myelofibrosis patients who have failed a type I JAK2 inhibitor.
LY5830966 is in Phase 1 clinical development. It is an investigational small molecule and is not FDA approved. The single Phase 1 trial is currently recruiting participants and has an enrollment target of 256 patients across the United States, France, Italy, Spain, and the United Kingdom.
LY5830966 is being evaluated in one Phase 1 trial, NCT06343805, titled a Phase 1 study of LY5830966 in participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have been failed by a type I JAK2 inhibitor. The trial is recruiting, controlled, and open to adults 18 years and older.