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Recruiting Phase 1 NCT05818683

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

Trial Parameters

Condition Metastatic Castration-resistant Prostate Neoplasms
Sponsor Janssen Research & Development, LLC
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 277
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2023-04-26
Completion 2026-06-30
Interventions
JNJ-78278343CetrelimabCabazitaxel

Brief Summary

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

Eligibility Criteria

Inclusion Criteria: * Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\]): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\>) 0.2 ng/mL despite being treated with next generation ARPI (apalutamide, enzalutamide, darolutamide) for between 180 and 365 days (inclusive); (b) Participant may not have progressed radiographically or have PSA progression while receiving androgen deprivation therapy (ADT) and ARPI, as defined by PCWG3 * Measurable or evaluable disease * (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with

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