Study of HLD-0915 for Metastatic Prostate Cancer

This study is testing a new oral medication called HLD-0915 in different forms (hard capsule, soft capsule, tablet) for men with metastatic prostate cancer (cancer that has spread to other parts of the body). The main goals are to find a safe dose of HLD-0915, understand its side effects, and see how well the different forms of the drug are absorbed by the body. Later parts of the study will also look at how effective HLD-0915 is against the cancer. You may be able to join if you are a man at least 18 years old with confirmed prostate cancer that has spread, and you have good blood, kidney, and liver function. The current status of the study is unclear, and it plans to enroll about 190 participants.

Study design
This is a Phase 1/2 study, meaning it first looks at safety and dosage, then expands to evaluate effectiveness. It is an open-label study, so both you and your doctors will know which treatment you are receiving.
What's involved
The study will measure the frequency and severity of side effects, and changes in your heart (ECG), lab tests, and clinical status over 21 to 22 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and drug absorption are measured at 21 to 22 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06800313

Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~190 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:JNJ-101556143 Formulation 1JNJ-101556143 Formulation 2JNJ-101556143 Formulation 3

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of dose-limiting toxicities (DLTs)
Measured over 21 days
+2 more outcomes measured
Metastatic Prostate Cancer
18 sites across 14 states
Colorado2
New York2
Tennessee2
Texas2
Connecticut1
Florida1
Louisiana1
Massachusetts1
  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

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  • Frequency of dose-limiting toxicities (DLTs)21 days
  • Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline21 days
  • Phase 1 Part 2 (formulation exploration) relative bioavailability22 days