Overview

A Study of JNJ-64619178, an Inhibitor of PRMT5 in Participants With Advanced Solid Tumors, NHL, and Lower Risk MDS

Status:
Active, not recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
JNJ-64619178
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