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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07441694 | Study of INCA036978 in Participants With Myeloproliferative Neoplasms | PHASE1 | RECRUITING | 218 | — | — | May 11, 2026 | May 24, 2030 | May 29, 2026 | 49 | United States, Australia +8 |
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...