Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64619178 · 1 trial · 4 indications
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
JNJ-64619178 is an investigational small molecule being studied for the treatment of neoplasms, including advanced solid tumors, non-Hodgkin lymphoma, and lower risk myelodysplastic syndromes. It is in Phase 1 clinical development for these oncology indications.
JNJ-64619178 is an inhibitor of PRMT5, as indicated in the clinical trial title. PRMT5 is a protein arginine methyltransferase involved in the regulation of gene expression and is a target of interest in oncology.
JNJ-64619178 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-64619178 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
JNJ-64619178 has been studied in one clinical trial, NCT03573310, titled 'A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS.' This Phase 1 trial enrolled 114 participants and has been completed.
No alternative names for JNJ-64619178 have been disclosed. It is referred to by its compound identifier in clinical trial records.