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A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | PHASE1 |
| Status | RECRUITING |
| Enrolment | 220 |
| Start date | Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Apr 12 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Neoplasms
Interventions
- JNJ-88549968
- Ruxolitinib
- Momelotinib
Countries
France, Italy, United Kingdom, Israel, Germany, Canada, United States, Spain