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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Metastatic Castration-resistant Prostate Neoplasms

Treatments: Drug: Cabazitaxel; Drug: Enzalutamide; Drug: Apalutamide; Drug: Cetrelimab; Drug: Abiraterone acetate plus prednisone (AAP); Drug: Docetaxel; Drug: JNJ-78278343; Drug: Darolutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05818683

78278343PCR1003 (Other Identifier)

CR109321

Details and patient eligibility

About

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).

Enrollment: 345 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• (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 chemotherapy (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 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, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, (Part 1B), docetaxel (Part 1C), apalutamide (Part 1D), enzalutamide (Part 1E), darolutamide (Part 1F), or abiraterone acetate + prednisone (AAP) (Part 1G)
• Significant infections or serious lung, heart or other medical conditions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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345 participants in 1 patient group

JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

Experimental group

Description:

Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).

Treatment:

Drug: Darolutamide

Drug: JNJ-78278343

Drug: Abiraterone acetate plus prednisone (AAP)

Drug: Docetaxel

Drug: Apalutamide

Drug: Cetrelimab

Drug: Enzalutamide

Drug: Cabazitaxel