A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants
NCT ID: NCT05022849
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2021-09-28
2037-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Part 1: Dose Escalation
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.
JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
Bridging Therapy
Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.
Part 2: Dose Expansion
Participants will receive JNJ-75229414 for each RP2D regimen determined in Part 1.
JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
Bridging Therapy
Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.
Interventions
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JNJ-75229414
JNJ-75229414 infusion will be administered intravenously.
Bridging Therapy
Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope Cancer Center
Duarte, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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75229414MPC1001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108972
Identifier Type: -
Identifier Source: org_study_id