Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

NCT05818683 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

Interventions

  • DRUG Docetaxel
  • DRUG Apalutamide
  • DRUG JNJ-78278343
  • DRUG Cetrelimab
  • DRUG Cabazitaxel

Study Locations (15)

Other

  • Icon Cancer Centre Kurralta Park — Kurralta Park
  • Macquarie University — Macquarie University
  • Peter MacCallum Cancer Centre — Melbourne
  • Princess Alexandra Hospital — Woolloongabba
  • Hosp Univ Vall D Hebron — Barcelona
  • Hosp Univ Fund Jimenez Diaz — Madrid
  • Hosp. Univ. 12 de Octubre — Madrid
  • Hosp Univ Hm Sanchinarro — Madrid

New York

  • Perlmutter Cancer Center at NYU Langone Brooklyn — Brooklyn
  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola
  • NYU Langone Health — New York

Florida

  • Florida Cancer Specialists — Sarasota

Michigan

  • Start Midwest — Grand Rapids

Missouri

  • Washington University School Of Medicine — St Louis

Pennsylvania

  • Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2023-04-26
Est. Completion 2027-09-01
Phase Phase 1

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05818683

The ClinicalTrials.gov registry entry for NCT05818683 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 277 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Metastatic Hormone-sensitive Prostate Cancer appearing as the primary indexed condition, and to 5 interventions — of which Docetaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05818683 reports 15 study locations spanning 6 distinct geographic areas — top geographies include Other, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05818683 about?

NCT05818683 is a clinical study titled "A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer". The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).

What is the current status of trial NCT05818683?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 277 participants. The study started on 2023-04-26. Estimated completion is 2027-09-01.

What conditions does trial NCT05818683 study?

This clinical trial studies the following conditions: Metastatic Hormone-sensitive Prostate Cancer, Metastatic Castration-resistant Prostate Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05818683?

The interventions under investigation include: Docetaxel (DRUG), Apalutamide (DRUG), JNJ-78278343 (DRUG), Cetrelimab (DRUG), Cabazitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05818683?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05818683 being conducted?

This trial has 15 study locations across Florida, Michigan, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial