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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07008118 | A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms | PHASE1 | RECRUITING | 120 | — | — | Oct 1, 2025 | Dec 14, 2029 | Apr 6, 2026 | 26 | United States, Australia +3 |
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+...