JNJ-64619178 for Cancer

Not currently recruiting at 25 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Disqualifiers: CNS involvement, Organ transplant, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks or longer if clinical benefit is observed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-64619178 for people with certain types of cancer. The study aims to determine the best dose for treating B cell non-Hodgkin lymphoma (a type of blood cancer) and advanced solid tumors, and to assess its safety for people with lower-risk myelodysplastic syndromes (a blood disorder). It suits those with these conditions who have at least one measurable site of disease and are generally in good health. Participants will receive the treatment, aiding researchers in understanding its effectiveness and impact on the body. As a Phase 1 trial, the research focuses on how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JNJ-64619178 is likely to be safe for humans?

Research has shown that JNJ-64619178 has been tested in people with various types of cancer. Studies have found that the treatment's side effects are generally manageable, meaning they are not too severe for most people. For solid tumors and non-Hodgkin lymphoma (NHL), the treatment showed some early signs of working against tumors. However, as the dose increased, so did the side effects, which is common in early studies like this one.

In people with lower-risk myelodysplastic syndromes (MDS), a condition affecting blood cells, researchers identified a safe dose. However, no clear evidence showed improvement in the condition. This means that while the drug is generally safe to take, its effectiveness for MDS remains uncertain. Overall, JNJ-64619178 appears to be relatively well-tolerated in humans, but more research is needed to confirm its benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-64619178 because it offers a novel approach to treating cancer, particularly myelodysplastic syndromes (MDS) and solid tumors. Unlike typical treatments that target cancer cells broadly, JNJ-64619178 is designed to selectively inhibit a specific enzyme involved in cancer cell growth, potentially reducing harm to healthy cells. This targeted mechanism could mean fewer side effects and more effective outcomes compared to standard chemotherapy or immunotherapy. Additionally, the flexibility in dosing based on patient response allows for personalized treatment, which is a significant advancement over the one-size-fits-all approach of many existing therapies.

What evidence suggests that JNJ-64619178 might be an effective treatment for cancer?

Studies have shown that JNJ-64619178, a drug that blocks the protein PRMT5, has manageable side effects and shows early signs of fighting tumors in people with solid tumors and non-Hodgkin lymphoma (NHL). In this trial, participants with solid tumors or NHL will receive JNJ-64619178 during the dose escalation and RP2D selection phase. This indicates that the treatment appears safe at certain doses and might help in fighting tumors. For participants with lower-risk myelodysplastic syndromes (MDS) in the dose confirmation and expansion phase, the drug was safe, but clear evidence of its effectiveness was not yet observed. Researchers believe this drug targets a protein involved in tumor growth, which is why they are interested in its potential to treat these cancers. Initial findings suggest that JNJ-64619178 might be promising, but further research is needed to confirm its efficacy. ^{1 2 3 4 6}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with B cell non-Hodgkin lymphoma, solid tumors, or lower risk myelodysplastic syndromes who are in good physical condition (ECOG score of 0-1) and have at least one measurable disease site. Women must test negative for pregnancy and agree not to donate eggs. People can't join if they've had certain recent cancer treatments or stem cell transplants, other cancers within the last 3 years (with some exceptions), known allergies to JNJ-64619178, prior organ transplants, or brain involvement by their cancer.

Inclusion Criteria

I have at least one tumor that can be measured.

I am fully active or restricted in physically strenuous activity but can do light work.

I have B cell non-Hodgkin lymphoma, a solid tumor, or lower risk MDS.

Exclusion Criteria

I had a stem cell transplant from my own cells within the last 9 months or received a transplant from a donor.

I haven't had cancer, except for certain skin cancers or cervical cancer in situ, in the last 3 years.

I have had a solid organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacokinetic Run-in

Participants undergo pharmacokinetic evaluations to determine drug absorption and metabolism

4 weeks

Treatment

Participants receive JNJ-64619178 with dose escalation to determine the maximum tolerated dose and recommended Phase 2 dose

24 weeks or longer if clinical benefit is observed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-64619178

Trial Overview The study is testing JNJ-64619178's highest dose that patients can tolerate without severe side effects in those with advanced cancers. It aims to find the best dose for Phase 2 trials (Part 1) and check its safety in people with less aggressive myelodysplastic syndromes (Part 2).

How Is the Trial Designed?

Group I: Part 2:Dose Confirmation and Expansion Experimental Treatment 1 Intervention

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 II: Part 1: Dose escalation and RP2D Selection Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145212623006550

Phase 1 study of JNJ-64619178, a protein arginine ... JNJ-64619178, a selective PRMT5 inhibitor, was studied in lower risk MDS patients. Dose-dependent myelosuppression was observed, and a tolerable dose was ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03573310

NCT03573310 | A Study of JNJ-64619178, an Inhibitor ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37776843/

Phase 1 study of JNJ-64619178, a protein arginine ... A tolerable dose of JNJ-64619178 was identified in patients with LR MDS. However, no evidence of clinical benefit was observed. Keywords: ...

4. aacrjournals.org aacrjournals.org/mct/article/20/12/2317/675158/Discovery-and-Pharmacological-Characterization-of

Discovery and Pharmacological Characterization of JNJ ... Here, we describe the characterization of JNJ-64619178, a novel, selective, and potent PRMT5 inhibitor, currently in clinical trials for patients with advanced ...

5. researchgate.net researchgate.net/publication/374072851_Phase_1_Study_of_JNJ-64619178_a_Protein_Arginine_Methyltransferase_5_Inhibitor_in_Patients_with_Lower-Risk_Myelodysplastic_Syndromes

Phase 1 Study of JNJ-64619178, a Protein Arginine ... A recent phase 1 clinical trial of the PRMT5 inhibitor JNJ-64619178 in patients with lower-risk MDS demonstrated target engagement and tolerability, although ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-jnj-64619178-an-inhibitor-of-prmt5-in-participants-with-advanced-solid-tumors-nhl-and

A Study of JNJ-64619178, an Inhibitor of PRMT5 in ... The purpose of the study is to identify the maximum tolerated dose (MTD) of JNJ-64619178 in participants with relapsed/refractory B cell ...