Actively Recruiting
Phase 1 Study of JNJ-87189401 and JNJ-78278343 Combination, with or without Apalutamide or Lutetium Lu-177 Vipivotide Tetraxetan, for Advanced Prostate Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-07-31
355
Participants Needed
18
Research Sites
53 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying advanced prostate cancer by evaluating combinations of investigational drugs JNJ-87189401 and JNJ-78278343, along with other treatments such as apalutamide, lutetium Lu-177 vipivotide tetraxetan, and JNJ-101556143. The study aims to identify recommended dosing regimens and assess the safety of these combinations in different parts of the trial, including dose escalation and safety evaluation phases. Participants in Part 1 will receive escalating doses of JNJ-78278343 and JNJ-87189401 to find the best dosing for Phase 2. Parts 2A and 2B will treat participants with the selected dosing regimen, while Part 2C will add apalutamide to the combination. Part 3 assesses safety when combining the drugs with standard lutetium Lu-177 vipivotide tetraxetan treatment, and Part 4 evaluates safety with the addition of JNJ-101556143. Throughout the study, participants will be closely monitored for dose-limiting toxicities and adverse events for up to nearly five years. Researchers will measure drug levels in the blood, immune responses, tumor responses, progression-free survival, and prostate-specific antigen levels. The study involves multiple treatment phases with ongoing safety assessments and long-term follow-up to understand how these drug combinations affect advanced prostate cancer.
CONDITIONS
Brief Title
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
Research Team
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Study Contact
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