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NCT05682443 · ClinicalTrials.gov registry record · Phase 1

ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by OncoC4.

Active
Registry status
Phase 1
Development phase
148
Enrollment target
20
Study locations

NCT05682443 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by OncoC4. The registered enrollment target is 148 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05682443, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by OncoC4.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
148 participants
Enrollment target
20
Study locations

Study Summary

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

Interventions

  • DRUG ONC-392 low
  • DRUG ONC-392 high
  • DRUG lutetium Lu 177 vipivotide tetraxetan

Study Locations (20)

New York

  • Roswell Park Comprehensive Cancer Center - Buffalo
  • NYU Langone Health, Laura & Isaac Perlmutter Cancer Center - New York
  • Columbia University Irving Cancer Center - New York

Maryland

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
  • Chesapeake Urology Research Associates - Towson

North Carolina

  • UNC North Carolina Comprehensive Cancer Care Center - Chapel Hill
  • Duke Cancer Center - Durham

California

  • UC Davis Comprehensive Cancer Center - Sacramento

Colorado

  • Rocky Mountain Cancer Centers USOR - Aurora

Florida

  • Moffitt Cancer Cancer - Tampa

Georgia

  • Emory University Winship Cancer Institute - Atlanta

Massachusetts

  • Lahey Hospital & Medical Center - Burlington

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2023-12-11
Est. Completion 2027-06-30
Phase Phase 1

Sponsor

OncoC4

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05682443

The ClinicalTrials.gov registry entry for NCT05682443 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (24% lower). The listed sponsor is OncoC4, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which ONC-392 low is the first listed.

NCT05682443 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05682443 about?

NCT05682443 is a clinical study titled "ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC". In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

What is the current status of trial NCT05682443?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 148 participants. The study started on 2023-12-11. Estimated completion is 2027-06-30.

What conditions does trial NCT05682443 study?

This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.

What interventions are being tested in trial NCT05682443?

The interventions under investigation include: ONC-392 low (DRUG), ONC-392 high (DRUG), lutetium Lu 177 vipivotide tetraxetan (DRUG).

Who is sponsoring clinical trial NCT05682443?

This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05682443 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. 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.