RecruitingPhase 1NCT06095089

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

250 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Prostate Cancer

Summary

The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria4

Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
Measurable or evaluable disease per PCWG3 criteria
Part 1, Part 2A and Part 2B: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria2

Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident