78278343PCR1003


78278343PCR1003: 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

Trial 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).

Receptor status / problem studied:

Inclusion criteria

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

2) Measurable or evaluable disease.

3)
|— 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 (e.g., 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 (i.e., abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel.

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

5) Adequate organ functions.

Exclusion criteria

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

2) 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).

3) Solid organ or bone marrow transplantation.

4) 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).

5) Significant infections or serious lung, heart or other medical conditions.

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Trial Title

78278343PCR1003

Diagnosis

Prostate cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

I

Investigators

Principal Investigator
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