Clinical trialNCT05682443Active, not recruitingPhase 1/PHASE2Interventional

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

SponsorOncoC4, Inc.Enrollment148Metastatic Castration-resistant Prostate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David Wise, MD
NYU Langone Health
Principal Investigator
clinicaltrials.gov ↗
Mark Stein, MD
Columbia University
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Uc Davis Comprehensive Cancer Center
Sacramento, California, United States
Rocky Mountain Cancer Centers Usor
Aurora, Colorado, United States
Moffitt Cancer Cancer
Tampa, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Xcancer/gu Research Network
Omaha, Nebraska, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Columbia University Irving Cancer Center
New York, New York, United States
Nyu Langone Health, Laura & Isaac Perlmutter Cancer Center
New York, New York, United States
Unc North Carolina Comprehensive Cancer Care Center
Chapel Hill, North Carolina, United States
Duke Cancer Center
Durham, North Carolina, United States
the Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ohsu Knight Cancer Institute
Portland, Oregon, United States
Ut Southwestern Medical Center
Dallas, Texas, United States
Virginia Cancer Specialists Usor
Fairfax, Virginia, United States
Virginia Oncology Associates Usor
Norfolk, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Usor
Norton, Virginia, United States
Uw Carbone Cancer Center
Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ONC-392 highONC-392 lowVipivotide tetraxetan →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Dec 2023
Primary completion: 30 Nov 2026
Completion: 30 Nov 2027
Last update posted: 22 May 2026
Registered enrollment: 148
Registry id: NCT05682443

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.