A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS
Completed · Phase 1
Conditions studied: Neoplasms, Solid Tumor, Adult, Non-Hodgkin Lymphoma, Myelodysplastic Syndromes
In brief
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).
Key facts
- Study ID
- NCT03573310
- Run by
- Janssen Research & Development, LLC
- People needed
- 114
- Starts
- 2018-07-13
- Expected to finish
- 2025-09-25
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of, or known, central nervous system (CNS) involvement
- 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
- 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
Where it is running
- Florida Specialist and Cancer Institute — Sarasota, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Ohio State University — Columbus, Ohio, United States
- University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
- St. Paul's Hospital — Vancouver, British Columbia, Canada
- Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
- Universitaetsklinikum Duesseldorf — Düsseldorf, Germany
- Goethe Universität Frankfurt — Frankfurt am Main, Germany
- Universitaetsklinikum Leipzig — Leipzig, Germany
- Carmel Medical Center — Haifa, Israel
- Hadassah Medical Center — Jerusalem, Israel
- Tel Aviv Sourasky MC — Tel Aviv, Israel
- Hosp. Univ. Germans Trias I Pujol — Badalona, Spain
- Hosp Univ Vall D Hebron — Barcelona, Spain
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain
- Clinica Univ. de Navarra — Pamplona, Spain
- Hosp Clinico Univ de Salamanca — Salamanca, Spain
- Hosp. Virgen Del Rocio — Seville, Spain
Full record on ClinicalTrials.gov
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