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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03573310 | A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS | PHASE1 | COMPLETED | 114 | — | — | Jul 13, 2018 | Sep 25, 2025 | Dec 18, 2025 | 18 | United States, Canada +3 |
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose escalation and RP2D Selection | EXPERIMENTAL | Participants with solid tumors or non-Hodgkin lymphoma (NHL) will receive JNJ-64619178 orally as per the assigned sequential cohorts and doses will be escalated based on the review of all available data including, but not limited to, pharmacokinetic, pharmacodynamic, safety, and clinical activity. One or more recommended Phase 2 dose(s) (RP2Ds) may be determined for further exploration. |
| Part 2:Dose Confirmation and Expansion | EXPERIMENTAL | Participants with myelodysplastic syndromes (MDS) will receive JNJ-64619178 at a dose less than or equal to the RP2D selected in Part 1 for 24 weeks, or longer if there is evidence of clinical benefit. The dose level of JNJ-64619178 may be adjusted based on observed toxicities. |
| Name | Type | Description |
|---|---|---|
| JNJ-64619178 | DRUG | JNJ-64619178 capsules to be administered orally. |
Inclusion Criteria: * B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS * At least 1 measurable site of disease for B cell-NHL and solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate organ function * Women of childbearing potenti...