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

NCT ID: NCT03573310

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2025-09-25

Brief Summary

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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).

Detailed Description

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The study is designed to determine the maximum tolerated dose (MTD) of JNJ-64619178, and to select a dose(s) and regimen(s) that may be used in future clinical development. Study evaluations will include safety, pharmacokinetics, biomarkers and efficacy evaluations (Disease Assessments). Adverse events will be evaluated throughout the study. The study is divided into 4 periods: a screening phase, a pharmacokinetic run-in phase, a treatment phase, and a post treatment follow-up phase. An end-of-treatment visit will be completed less than or equal (\<=) 30 days (+7 days) after the last dose of study drug or prior to the start of a new anticancer therapy, whichever comes first.

Conditions

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Neoplasms Solid Tumor, Adult Non-Hodgkin Lymphoma Myelodysplastic Syndromes

Keywords

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Lower risk MDS Low risk MDS Lower-risk MDS Low-risk MDS Intermediate 1 risk MDS Intermediate-1 risk MDS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose escalation and RP2D Selection

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.

Group Type EXPERIMENTAL

JNJ-64619178

Intervention Type DRUG

JNJ-64619178 capsules to be administered orally.

Part 2:Dose Confirmation and Expansion

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.

Group Type EXPERIMENTAL

JNJ-64619178

Intervention Type DRUG

JNJ-64619178 capsules to be administered orally.

Interventions

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JNJ-64619178

JNJ-64619178 capsules to be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Florida Specialist and Cancer Institute

Sarasota, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, Canada

Site Status

Universitaetsklinikum Duesseldorf

Düsseldorf, , Germany

Site Status

Goethe Universität Frankfurt

Frankfurt am Main, , Germany

Site Status

Universitaetsklinikum Leipzig

Leipzig, , Germany

Site Status

Carmel Medical Center

Haifa, , Israel

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Tel Aviv Sourasky MC

Tel Aviv, , Israel

Site Status

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Site Status

Hosp Univ Vall D Hebron

Barcelona, , Spain

Site Status

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Site Status

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status

Hosp. Virgen Del Rocio

Seville, , Spain

Site Status

Countries

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United States Canada Germany Israel Spain

Other Identifiers

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CR108485

Identifier Type: -

Identifier Source: org_study_id

64619178EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

2018-000067-87

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-515254-24-00

Identifier Type: REGISTRY

Identifier Source: secondary_id