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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Margaret Cancer Centre - University Health Network
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Universitaetsklinikum Duesseldorf
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DüsseldorfGermanyUnknown status
Goethe Universität Frankfurt
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Frankfurt am MainGermanyUnknown status
Universitaetsklinikum Leipzig
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LeipzigGermanyUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Carmel Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Tel-Aviv Sourasky MC
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Tel AvivIsraelUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Ohio State University
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ColumbusUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Florida Specialist and Cancer Institute
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.