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ACTIVE NOT RECRUITING Phase 1

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

NCT05682443 · View on ClinicalTrials.gov ↗

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.

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

6 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. 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 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OncoC4, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05682443 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, Maryland, North Carolina. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05682443?

This trial is sponsored by OncoC4, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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