JNJ-64619178 for Cancer

Recruiting at 23 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

114 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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).

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires