A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS
Neoplasms, Solid Tumor, Adult, Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Lower risk MDS, Low risk MDS, Lower-risk MDS, Low-risk MDS, Intermediate 1 risk MDS, Intermediate-1 risk MDS
Eligibility Criteria
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 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
Exclusion Criteria:
- 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
Sites / Locations
- Florida Specialist and Cancer Institute
- Massachusetts General Hospital
- Ohio State University
- University of Texas, MD Anderson Cancer Center
- St. Paul's Hospital
- University of Toronto
- Universitaetsklinikum Duesseldorf
- Goethe Universität Frankfurt
- Universitaetsklinikum Leipzig
- Carmel Medical Center
- Hadassah Medical Center
- Tel Aviv Sourasky MC
- Hosp. Univ. Germans Trias I Pujol
- Hosp. Univ. Vall D Hebron
- Hosp. Univ. Fund. Jimenez Diaz
- Clinica Univ. de Navarra
- Hosp. Clinico Univ. de Salamanca
- Hosp. Virgen Del Rocio
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1: Dose escalation and RP2D Selection
Part 2:Dose Confirmation and Expansion
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.
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.