NCT03573310CompletedPhase 1
A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS
A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell non-Hodgkin lymphoma (NHL) or advanced solid tumors and also to identify the recommended Phase 2 dose(s) (RP2Ds) of JNJ-64619178 for NHL and advanced solid tumors (Part 1) and to confirm the tolerability of JNJ-64619178 in participants with lower risk myelodysplastic syndromes (MDS) (Part 2).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 114 (actual)
- First submitted
- 20 Jun 2018
- Start date
- 13 Jul 2018
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT03573310
- EU CT number
- 2024-515254-24-00
- EudraCT number
- 2018-000067-87
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 114
- From 13 Jul 2018 to the primary completion date, 25 Sept 2025
- 13 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior solid organ transplantation
- Either of the following: a) Received an autologous stem cell transplant less than or equal (\<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant
Other illness
- History of, or known, central nervous system (CNS) involvement
- History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
- Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient
Who the study is looking for
- 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 potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Universitaetsklinikum Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Goethe Universität Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Unknown status |
| Universitaetsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Tel-Aviv Sourasky MC Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Florida Specialist and Cancer Institute Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.