drugset / Trial / NCT06150157

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

NCT06150157

Phase 1 Recruiting 241 enrolled Janssen Research & Development, LLC
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2023-12-20
Primary completion
2026-12-04
Completion
2028-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject JNJ-88549968 Unknown
Subject Momelotinib Small molecule
Subject Ruxolitinib Small molecule

Indications