JNJ-75229414 for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

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.

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.

+2 more

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.

+2 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions

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

Group II: Part 1: Dose EscalationExperimental Treatment2 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.