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

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male
Study Type
Other
NCT ID
NCT05022849
Protocol IDs
CR108972 (primary)
NCI-2021-12359
75229414MPC1001
Study Sponsor
Janssen Research & Development, LLC

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).

Eligibility

  1. Histology: Metastatic CRPC (mCRPC) with histologic confirmation of adenocarcinoma. Metastatic CRPC with neuroendocrine features or mixed histology is excluded
  2. 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)
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
  4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or detectable prostate-specific antigen (PSA) levels based on local laboratory results
  5. 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
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.