JNJ-75229414 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called JNJ-75229414 for prostate cancer that has spread and resists standard hormone therapies. The study aims to determine the best dose of the treatment in the first part and to assess its safety at that dose in the second part. Participants may also receive other therapies to help stabilize the cancer. The trial seeks individuals with metastatic castration-resistant prostate cancer (mCRPC) who have previously tried at least one hormone or chemotherapy treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires a break from certain medications before starting. You need to stop anti-androgen agents and PARP inhibitors at least 2 weeks before, and cytotoxic chemotherapy or investigational agents at least 3 weeks before joining the study.
Is there any evidence suggesting that JNJ-75229414 is likely to be safe for humans?
Research has shown that JNJ-75229414 is still under study to determine the appropriate dose for future research. This treatment is a type of CAR-T therapy, which involves modifying a patient's immune cells to enhance their ability to fight cancer. As this treatment is in the early testing stages, limited safety data is available.
The trial's main goal is to establish a safe dose and identify any side effects. Researchers will closely monitor participants to assess their response to the treatment and detect any side effects.
Currently, safety information is still being gathered, and joining this trial contributes to understanding the safety of this new treatment.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for prostate cancer, which typically involve hormone therapy, chemotherapy, or surgery, JNJ-75229414 offers a novel approach by using a targeted infusion therapy. This experimental treatment is designed to work alongside a conditioning regimen of cyclophosphamide and fludarabine to optimize its effectiveness. Researchers are particularly excited about JNJ-75229414 because it aims to determine the optimal dose that maximizes efficacy while minimizing side effects, potentially offering a more personalized treatment option for patients with prostate cancer.
What evidence suggests that JNJ-75229414 might be an effective treatment for prostate cancer?
Research has shown that JNJ-75229414 is under investigation as a potential treatment for advanced prostate cancer. The trial consists of two parts: Part 1 focuses on dose escalation to determine the recommended Phase 2 dose (RP2D), while Part 2 involves dose expansion for each RP2D regimen identified in Part 1. This treatment targets patients whose cancer has spread and no longer responds to hormone therapy. Early studies have concentrated on identifying the correct dose and ensuring the treatment's safety. In these studies, about 8% of patients experienced tumor shrinkage, which is promising for those with advanced, hard-to-treat cancer. The drug targets specific proteins that aid cancer growth, offering a novel approach to treatment.13456
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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)
Dose Expansion
Participants receive JNJ-75229414 for each RP2D regimen determined in Part 1
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
ASCO 2025 – J&J takes another prostate cancer shot
Overall response rates didn't look as impressive with pasritamig, at 8% – but this was only given across the entire trial, not just the go- ...
2.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-jnj-75229414-for-metastatic-castration-resistant-prostate-cancer-participantsA Study of JNJ-75229414 for Metastatic Castration-resistant ...
The purpose of this study is to determine recommended Phase 2 dose (RP2D) regimen(s) of JNJ-75229414 in Part 1 (Dose Escalation and to determine safety at ...
JNJ-75229414 for Prostate Cancer · Info for Participants
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 ...
Developmental Therapeutics in Metastatic Prostate Cancer
To obtain a full assessment of the therapeutic potential of KLK2, Janssen Research & Development also developed JNJ-75229414, a genetically ...
Study of JNJ-75229414 in Patients with Metastatic Castration ...
The purpose of this study is to see if a new, experimental drug called JNJ-75229414 is safe and useful for treating patients with metastatic castration- ...
JNJ 75229414 - AdisInsight - Springer
JNJ 75229414 is a chimeric antigen receptor T Cell (CAR-T) therapy directed against kallikrein related peptidase 2 (KLK2), being developed ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.