A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to identify the recommended phase 2 doses (RP2Ds) of JNJ-78278343 with cetrelimab (JNJ-63723283) in Part 1 (dose escalation) and to determine safety at the RP2D(s) in Part 2 (dose expansion).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)

• Measurable or evaluable disease.

• Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ functions

Exclusion Criteria:

• Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications

• Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)

• Solid organ or bone marrow transplantation

• Known allergies, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab

• Significant infections or serious lung, heart or other medical conditions