← Back to Search

Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor

JNJ-64619178 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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

Prior solid organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see what doses are tolerated by patients with different types of cancer, including lymphoma and solid tumors. The goal is to also find out what doses of the drug might be effective in treating these cancers.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Specific side effects of JNJ-64619178 aren't listed here but generally may include reactions related to immune system activation, such as inflammation in various organs; infusion-related reactions; fatigue; gastrointestinal issues like nausea or diarrhea; blood count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least one tumor that can be measured.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have had a solid organ transplant.

Select...

My cancer has spread to my brain or spinal cord.

Select...

I am allergic to JNJ-64619178 or its ingredients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Part 1 and Part 2: Accumulation Index (RA)

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

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

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2:Dose Confirmation and ExpansionExperimental Treatment1 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 SelectionExperimental Treatment1 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.

0 / 7Eligibility criteria met