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

NCT03573310 | Completed Phase 1 FDA Drug

• 4 other identifiers: CR10848564619178EDI10012018-000067-872024-515254-24-00
• Study Type: interventional
• Target: 114
• Locations: 5 countries
• Sites: 18

Brief 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).

Conditions

Neoplasms; Solid Tumor, Adult; Non-Hodgkin Lymphoma; Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Part 1 and Part 2: Number of Participants with Dose-limiting Toxicities (DLTs)

  DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

  Approximately 3 years

Secondary Outcomes (19)

• Part 1 and Part 2: Number of Participants with Adverse Events (AE)

  Approximately 3 years

• Part 1 and Part 2: Number of Participants with AE by Severity

  Approximately 3 years

• Part 1 and Part 2: Number of Participants with Abnormal Vital Signs

  Approximately 3 years

• Part 1 and Part 2: Number of Participants with Laboratory Abnormalities

  Approximately 3 years

• Part 1 and Part 2: Number of Participants with Electrocardiogram (ECG) Abnormalities

  Approximately 3 years

Study Arms (2)

Part 1: Dose escalation and RP2D Selection

EXPERIMENTAL

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.

Drug: JNJ-64619178

Part 2:Dose Confirmation and Expansion

EXPERIMENTAL

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.

Drug: JNJ-64619178

Interventions

JNJ-64619178 DRUG

JNJ-64619178 capsules to be administered orally.

Part 1: Dose escalation and RP2D Selection; Part 2:Dose Confirmation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (18)

Florida Specialist and Cancer Institute

Sarasota, Florida, 34232, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, M5G1Z5, Canada

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Goethe Universität Frankfurt

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Tel Aviv Sourasky MC

Tel Aviv, 6423906, Israel

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma, Non-Hodgkin; Myelodysplastic Syndromes

Interventions

JNJ-64619178

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Hematologic Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: June 29, 2018
• Study Start: July 13, 2018
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

DE (3); CA (2); IL (3); ES (6); US (4)