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RecruitingPhase 1

A Study of JNJ-87189401 Combined With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people with advanced prostate cancer. It tests JNJ-87189401 with JNJ-78278343 to find a dosing plan for future study and check safety. Some parts also test adding apalutamide, the standard treatment lutetium Lu-177 vipivotide tetraxetan, or JNJ-101556143.

The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of cancer, confirmed by a tissue test. Some small cell or neuroendocrine features are allowed.
  • Have cancer that can be measured or checked using the study’s rules.
  • For Parts 1, 2A, 2B, 3, and 4: Have had surgery to remove the testicles or treatment to lower testosterone. If you have not had this surgery, you must take a hormone-blocking medicine called a GnRH drug before and throughout study treatment.
  • Be fully active, or able to walk and do light work but limited in hard physical activity.

Who can't join

  • Have small cell carcinoma, a carcinoid tumor, mixed neuroendocrine carcinoma, or large cell neuroendocrine carcinoma. These are specific cancer types.
  • Have had an autoimmune disease, where the body’s defenses attack healthy tissue, in the 12 months before signing the consent form.
  • Have had a heart attack, severe or unstable chest pain, or serious abnormal rhythms in the heart’s lower chambers in the 6 months before signing the consent form.
  • Have had heart failure rated class II to IV, meaning the heart does not pump well and symptoms limit activity or occur at rest, in the 6 months before signing the consent form.
  • Have had a stroke or a mini-stroke in the 6 months before signing the consent form.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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, Parts 2A, 2B, 3 and 4: 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 Criteria: * History of an autoimmune disease within the 12 months prior to signing consent * 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

Study sites (12)

CO

GA

MN

NC

NJ

NY

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center · New York, NY 10032More trials in New York

OR

PA

TN

TX

WA