JNJ-75229414 for Prostate Cancer

Recruiting at 9 trial locations

Overseen By Study Contact

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

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

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called JNJ-75229414 to find the safest and most effective dose for patients. The study will identify the best dose and ensure it is safe.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for men with advanced prostate cancer that has spread and doesn't respond to hormone therapy. They should have tried at least one other treatment like abiraterone or chemotherapy, be relatively healthy (ECOG grade 0 or 1), and either have measurable disease or detectable PSA levels. Men must use contraception during the study.

Inclusion Criteria

My cancer can be measured by scans or has detectable PSA levels.

I have previously been treated with specific prostate cancer medications or chemotherapy.

I agree to use a condom and spermicide during sex for 1 year after my last treatment dose.

Exclusion Criteria

I have experienced severe immune or nerve side effects from previous cancer treatment.

I haven't had systemic treatment for cancer, other than prostate cancer, in the last 6 months.

I haven't had certain cancer treatments in the last 2-3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive a conditioning regimen of cyclophosphamide and fludarabine followed by JNJ-75229414 IV infusion to determine recommended Phase 2 dose (RP2D) regimen(s)

Up to 28 days

Dose Expansion

Participants receive JNJ-75229414 for each RP2D regimen determined in Part 1

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years 9 months

Treatment Details

Interventions

• JNJ-75229414

Trial Overview The trial is testing JNJ-75229414's safety and optimal dose in two parts: first finding the best dose, then seeing how safe it is at that dose. It includes a bridging therapy phase where patients transition from their previous treatments.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 2 Interventions

Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.

Group II: Part 1: Dose Escalation Experimental Treatment 2 Interventions

Participants will receive a conditioning regimen of cyclophosphamide and fludarabine intravenously (IV) followed by JNJ-75229414 IV infusion escalated sequentially with a targeted dose consistent with the dose required by the cohort being enrolled to determine recommended Phase 2 dose (RP2D) regimen(s). Additional, intermediate dose levels may be implemented based on the review of all available data including, but not limited to, safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) by the study evaluation team (SET). Participants may receive bridging therapy (anti-androgen receptor agents \[example, abiraterone, enzalutamide\] and radiotherapy, or chemotherapy \[example, docetaxel\]) if clinically indicated to maintain disease stability.

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