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NCT04644770 · ClinicalTrials.gov registry record · Phase 1

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

A Phase 1 study of Prostatic Neoplasms and Adenocarcinoma, sponsored by Janssen Research & Development.

Active
Registry status
Phase 1
Development phase
144
Enrollment target
11
Study locations

NCT04644770 is a Phase 1 study of Prostatic Neoplasms and Adenocarcinoma that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 144 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (72% lower). The trial reports 11 study locations across 10 states.

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The verdict

NCT04644770, a Phase 1 study of Prostatic Neoplasms and Adenocarcinoma, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
144 participants
Enrollment target
11
Study locations

Study Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part 3 (combination therapy) and to determine safety of JNJ-69086420 at the RP2D(s) in participants with metastatic hormone-sensitive prostate cancer (mHSPC) in Part 4.

Conditions Studied

Prostatic Neoplasms Adenocarcinoma

Interventions

  • DRUG JNJ-78278343
  • RADIATION Stereotactic body radiation therapy
  • DRUG JNJ-69086420

Study Locations (11)

Louisiana

  • East Jefferson General Hospital - Metairie
  • Tulane University Hospital & Clinics - New Orleans

Arizona

  • Mayo Clinic Arizona - Phoenix

California

  • City of Hope - Duarte

Florida

  • Mayo Clinic in Florida - Jacksonville

Illinois

  • University of Chicago - Chicago

Minnesota

  • Mayo Clinic Rochester - Rochester

Nebraska

  • XCancer Omaha / Urology Cancer Center - Omaha

New York

  • Memorial Sloan Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2020-11-12
Est. Completion 2027-01-15
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04644770

The ClinicalTrials.gov registry entry for NCT04644770 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (72% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which JNJ-78278343 is the first listed.

NCT04644770 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Louisiana, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT04644770 about?

NCT04644770 is a clinical study titled "A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer". The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combina...

What is the current status of trial NCT04644770?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2020-11-12. Estimated completion is 2027-01-15.

What conditions does trial NCT04644770 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Adenocarcinoma.

What interventions are being tested in trial NCT04644770?

The interventions under investigation include: JNJ-78278343 (DRUG), Stereotactic body radiation therapy (RADIATION), JNJ-69086420 (DRUG).

Who is sponsoring clinical trial NCT04644770?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04644770 being conducted?

This trial has 11 study locations across Arizona, California, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.