A Study of JNJ-87189401 and JNJ-78278343 for Advanced Prostate Cancer
This study is looking at new combinations of medicines for men with advanced prostate cancer. It will test JNJ-87189401 and JNJ-78278343, sometimes with other approved drugs like apalutamide or Lutetium Lu-177 Vipivotide Tetraxetan, and also with JNJ-101556143. The main goal is to find out the safest dose of these combinations and to see how many side effects participants experience. To join, you must be a man aged 18 or older with prostate cancer that has been confirmed by a biopsy. The study is planned to include 355 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 355 participants. The study aims to determine recommended drug regimens and evaluate their safety.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for adverse events for up to 4 years and 8 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
At a glance
Conditions
Where it's being run
19 sites across 15 statesStudy leadership
- Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)Up to 21 days after first combination dose of study drugs
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
- Number of Participants with Adverse Events (AEs) by SeverityUp to 4 years 8 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.