A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Aug 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-75229414 for men with metastatic castration-resistant prostate cancer (mCRPC), which is a type of prostate cancer that has spread and no longer responds to standard hormone treatments. The trial has two parts: the first part will find the best dose of the treatment, and the second part will assess how safe that dose is for patients. Currently, the trial is active but not recruiting new participants.

To be eligible for this study, participants must be men aged 65 to 74 who have a confirmed diagnosis of mCRPC and have previously tried at least one other hormone therapy or chemotherapy. They should be in good overall health, with a performance status of 0 or 1, meaning they can carry out daily activities with minimal issues. It's also important for participants to use effective contraception during the study to prevent any risk of pregnancy. If you or someone you know is considering this trial, it's a chance to access a new treatment option while contributing to important research in prostate cancer care.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histology: Metastatic CRPC (mCRPC) with histologic confirmation of adenocarcinoma. Metastatic CRPC with neuroendocrine features or mixed histology is excluded
• • Prior Therapy: Prior treatment with at least 1 prior novel androgen receptor AR-targeted therapy (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or at least 1 prior chemotherapy (example, docetaxel)
• • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
• • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
• • Fertile participants must use a condom with spermicide during any sexual contact with a woman of childbearing potential, including pregnant women, from the time of signing the ICF until 1 year after receiving a JNJ-75229414 infusion. Vasectomized participants must agree to use a condom to protect any sexual partner from exposure to semen for 1 year after receiving the last dose of study drug. Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
• Exclusion Criteria:
• • Prior Grade 4 Cytokine release syndrome (CRS) or Grade 3 or Grade 4 neurotoxicity related to any T cell redirection (Bispecific cluster of differentiation \[CD 3\])
• • Prior Kallikrein 2 (KLK2)-targeted therapy
• • Prior chimeric antigen receptor T cell (CAR-T) therapy
• • Receiving systemic treatment less than or equal to (\<=) 6 months prior to signing informed consent) for any invasive malignancy other than prostate cancer unless approved by the sponsor. Bisphosphonates initiated greater than or equal to (\>=) 6 weeks prior signing informed consent are allowed
• • Less than 2 weeks between last administration anti-androgen agents (example, abiraterone or enzalutamide), poly adenosine diphosphate-ribose polymerase (PARP) inhibitors (example, olaparib) or radiotherapy, and less than 3 weeks between last administration of cytotoxic chemotherapy (example, docetaxel), radionuclides (example, radium-223, lutetium-177-Prostate-specific membrane antigen \[PSMA\]-617) or an investigational agent, and apheresis