Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07469891 | A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms | PHASE1 | RECRUITING | 100 | — | — | Apr 29, 2026 | Apr 1, 2028 | May 29, 2026 | 3 | United States |
Incidence of dose limiting toxicities, defined according to protocol-specified criteria
Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Incidence of AEs leading to dose reductions, dose interruptions, treatment discontinuations, and clinically significant laboratory abnormalities
Determination of the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]) based on evaluation of DLTs, safety, and tolerability data
| Arm | Type | Description |
|---|---|---|
| PRT12396: MF | EXPERIMENTAL | Participants with myelofibrosis receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE) |
| PRT12396: PV | EXPERIMENTAL | Participants with polycythemia vera receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE) |
| Name | Type | Description |
|---|---|---|
| PRT12396 | DRUG | PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals. |
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures. * Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria * Docum...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Protagonist Therapeutics, Inc. | PTGX | 2 | PHASE3 | Rusfertide, Open-label rusfertide |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Ionis Pharmaceuticals, Inc. | IONS | 1 | PHASE2 | sapablursen |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-3405 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |