Prostate Cancer Clinical Trial

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

Summary

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 the RP2D regimen(s) in Part 2 (Dose Expansion).

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT05022849

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 11 Locations for this study

See Locations Near You

City of Hope Cancer Center
Duarte California, 91010, United States
Cedars-Sinai Medical Center
West Hollywood California, 90048, United States
Emory University - Winship Cancer Institute
Atlanta Georgia, 30322, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University Of Minnesota
Minneapolis Minnesota, 55455, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Utah Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT05022849

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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