AzTrials
AzTrials

NeoplasmsPhase 1NCT03573310

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

A Phase 1 study testing JNJ-64619178 in people with Neoplasms and Solid Tumor, Adult, run by Janssen Research & Development, LLC at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-64619178
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
18 sitesin 5 countries
Study dates
13 Jul 2018to 25 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

Spain6 sites
  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Virgen Del Rocio

    Seville, 41013

Other trials in Spain

United States4 sites
  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Florida Specialist and Cancer Institute

    Sarasota, Florida, 34232

Other trials in United States

Germany3 sites
  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Goethe Universität Frankfurt

    Frankfurt am Main, 60590

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

Israel3 sites
  • Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906

Other trials in Israel

Canada2 sites
  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G1Z5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

About this study

Official title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64619178, an Inhibitor of Protein Arginine Methyltransferase 5 (PRMT5) in Subjects With Advanced Cancers

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).

Read the detailed description

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.

Being tested
JNJ-64619178
Keywords
Lower risk MDS, Low risk MDS, Lower-risk MDS, Low-risk MDS, Intermediate 1 risk MDS, Intermediate-1 risk MDS
Medical subject headings
Neoplasms, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64619178Drug

    JNJ-64619178 capsules to be administered orally.

Study groups in NCT03573310
Study groupRoleWhat they receive
Part 1: Dose escalation and RP2D SelectionExperimentalParticipants 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.
Receives: Drug: JNJ-64619178
Part 2:Dose Confirmation and ExpansionExperimentalParticipants 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.
Receives: Drug: JNJ-64619178

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 3 years

Secondary outcomes (19)
  1. Part 1 and Part 2: Number of Participants with Adverse Events (AE)

    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

    Measured: Approximately 3 years

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

    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

    Measured: Approximately 3 years

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

    Number of participants with abnormality in vital signs (temperature, pulse/heart rate, and blood pressure) will be reported.

    Measured: Approximately 3 years

  4. Part 1 and Part 2: Number of Participants with Laboratory Abnormalities

    Number of participants with laboratory abnormalities (serum chemistry, hematology, and coagulation, and disease-related laboratory abnormalities) will be reported.

    Measured: Approximately 3 years

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

    Number of participants with electrocardiogram(ECG) abnormalities will be reported.

    Measured: Approximately 3 years

  6. Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of JNJ-64619178

    Cmax is the maximum observed plasma concentration.

    Measured: Approximately 3 years

  7. Part 1 and Part 2: Area Under the Plasma Concentration Versus Time Curve From Time Zero to End of Dosing Interval (AUCtau)

    AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.

    Measured: Approximately 3 years

  8. Part 1 and Part 2: Minimum Plasma Concentration (Cmin)

    Cmin is the minimum observed plasma concentration.

    Measured: Approximately 3 years

  9. Part 1 and Part 2: Plasma Decay Half-Life (t1/2)

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: Approximately 3 years

  10. Part 1 and Part 2: Volume of Distribution at Steady-State Influenced by the Fraction Absorbed (Vss/F)

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady state which is estimated by (D/AUC[0-infinity])* (AUMC[0-infinity])/(AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. All these parameters will be assessed as influenced by the fraction absorbed.

    Measured: Approximately 3 years

  11. Part 1 and Part 2: Apparent Total Systemic Clearance of Drug (CL/F) after Extravascular Administration

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

    Measured: Approximately 3 years

  12. Part 1 and Part 2: Accumulation Index (RA)

    Accumulation Index (RA) is calculated as AUC (0-24) value at steady state divided by AUC (0-24) value after first dose.

    Measured: Approximately 3 years

  13. Part 1 and Part 2: Plasma Concentration of Symmetric Dimethyl-Arginine (SDMA)

    Plasma concentration of symmetric dimethyl-arginine (SDMA) will be evaluated.

    Measured: Approximately 3 years

  14. Part 1: Percentage of Participants with B cell non-Hodgkin lymphoma (NHL) Showing Overall Response of Partial Response (PR) or Better

    Overall response rate (ORR) is defined as the percentage of participants who have a PR or better. Per Lugano classification, PR is defined as greater than or equal (>=) 50 percent (%) decrease in size of target lesions.

    Measured: Approximately 3 years

  15. Part 1: Percentage of Participants with Solid Tumors Showing Overall Response of PR or Better

    Overall response rate (ORR) is defined as the percentage of participants who have a PR or better. PR criteria in solid tumors (RECIST) is >= 30 percent (%) decrease in the sum of the diameters of all index lesions compared with baseline in 2 observations at least 4 weeks apart, in absence of new lesions or unequivocal progression of non-index lesions.

    Measured: Approximately 3 years

  16. Part 1: Duration of Response

    Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD), as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. PD (per RECIST 1.1) defined as at least 20% increase in the sum of the longest diameters of index lesions or unequivocal progression of non-index lesions. Per Lugano classification, PD: target lesions larger; clear progression of non-target lesions; or new tumor lesions; new or recurrent bone marrow involvement; splenomegaly + 2 centimeter (cm) or +50%.

    Measured: Approximately 3 years

  17. Part 1: Clinical Benefit Rate

    Clinical benefit rate is defined as percentage of participants who have a complete response (CR), PR and sustained stable disease of 12 weeks or more. Sustained stable disease of 12 weeks or more is defined as participants with stable disease assessment maintained for about 12 weeks or longer from baseline. Per Lugano classification CR is defined as no detectable disease by computed tomography (CT) or positron emission tomography (PET)/CT scan. Evaluation criteria as per RECIST 1.1 for CR is defined as disappearance of all lesions in 2 consecutive observations not less than 4 weeks apart.

    Measured: Approximately 3 years

  18. Part 2: Red Blood Cell (RBC) Transfusion Independence (TI) Rate

    Percentage of participants with TI, defined as being without any transfusion during any consecutive 8 weeks (56 days) between the first dose of study drug and treatment discontinuation.

    Measured: Approximately 3 years

  19. Part 2: Overall Improvement Rate

    Overall improvement rate is defined as the percentage of participants achieving complete remission (bone marrow: less than or equal to (<=)5% myeloblasts with normal maturation of all cell lines; Peripheral blood: hemoglobin >=11 gram per deciliter (g/dL); platelets >=100*109/liter(L); neutrophils >=1.0*109/L; blasts, 0%), partial remission (All complete remission criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% over pretreatment but still >5% Cellularity and morphology not relevant), or hematologic improvement (HI) (Erythroid response [pretreatment, <11 g/dL]; Platelet response (pretreatment, <100*10^9/L); Neutrophil response (pretreatment, <1*10^9/L); Progression or relapse after HI) according to modified International Working Group (IWG) criteria.

    Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start13 Jul 2018
  3. Primary completion25 Sep 2025
  4. Study completion25 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573310
Sponsor's protocol ID
CR108485
Other IDs
64619178EDI1001, 2018-000067-87, 2024-515254-24-00, 2018
Status last verified
Dec 2025
First submitted
20 Jun 2018
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64619178 in people with Neoplasms and Solid Tumor, Adult, run by Janssen Research & Development, LLC at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, United States, Germany, Israel, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and Part 2: Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in