A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

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A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06095089
Protocol IDs
CR109330 (primary)
NCI-2023-09674
2023
2023-504063-17-00
87189401PCR1001
Study Sponsor
Janssen Research & Development, LLC

Summary

The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen
for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of
Part 2C of this study is to determine how safe the RP2R(s) of the combination of
JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study
evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with
standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study
further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343
with JNJ-101556143 in participants with advanced prostate cancer.

Eligibility

  1. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
  2. Measurable or evaluable disease per PCWG3 criteria
  3. Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
  4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.