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 (dosethe amount of medication taken escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
Intervention / Treatment
- Drug: JNJ-78278343
- Drug: Cetrelimab
- Drug: Cabazitaxel
- Drug: Docetaxel
- Drug: Apalutamide
- Drug: Enzalutamide
- Drug: Darolutamide
- Drug: Abiraterone acetate plus prednisone (AAP)
Inclusion Criteria:
- Metastatic castration-resistant prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (mCRPC) with confirmed adenocarcinomacancer arising from mucus-producing glands in organs of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
- Measurable or evaluable disease.
- (a) Part 1A: JNJ-78278343 + cetrelimab – Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells (eg, docetaxel). (b) Part 1C: JNJ-78278343 + docetaxel, Part 1D: JNJ-78278343 + apalutamide, Part 1E: JNJ-78278343 + enzalutamide, Part 1F: JNJ-78278343 + darolutamide, and Part 1G: JNJ-78278343 + abiraterone acetate + prednisone – Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate,). (C) Part 1B: JNJ-78278343 + cabazitaxel – Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Adequate organ functions.