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Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05682443

Public ClinicalTrials.gov record NCT05682443. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 30, 2026, 12:13 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05682443
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
OncoC4, Inc.
Industry
Enrollment
148 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 11, 2023 (Actual)
Primary completion
Nov 30, 2026 (Estimated)
Completion
Nov 30, 2027 (Estimated)
Last update posted
May 22, 2026

2023 – 2027

United States locations

U.S. sites
23
U.S. states
17
U.S. cities
22
Facility City State ZIP Site status
UC Davis Comprehensive Cancer Center Sacramento California 95817 —
Rocky Mountain Cancer Centers USOR Aurora Colorado 80012 —
Moffitt Cancer Cancer Tampa Florida 33612 —
Emory University Winship Cancer Institute Atlanta Georgia 30322 —
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21202 —
Chesapeake Urology Research Associates Towson Maryland 21204 —
Lahey Hospital & Medical Center Burlington Massachusetts 01805 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
XCancer/GU Research Network Omaha Nebraska 68130 —
Rutgers Cancer Institute New Brunswick New Jersey 08901 —
New Mexico Oncology Hematology Consultants Albuquerque New Mexico 87109 —
Roswell Park Comprehensive Cancer Center Buffalo New York 14203 —
NYU Langone Health, Laura & Isaac Perlmutter Cancer Center New York New York 10016 —
Columbia University Irving Cancer Center New York New York 10032 —
UNC North Carolina Comprehensive Cancer Care Center Chapel Hill North Carolina 27514 —
Duke Cancer Center Durham North Carolina 27710 —
The Ohio State University Comprehensive Cancer Center Columbus Ohio 43210 —
OHSU Knight Cancer Institute Portland Oregon 97210 —
UT Southwestern Medical Center Dallas Texas 75390 —
Virginia Cancer Specialists USOR Fairfax Virginia 22031 —
Virginia Oncology Associates USOR Norfolk Virginia 23502 —
Oncology and Hematology Associates Of Southwest Virginia USOR Norton Virginia 24273 —
UW Carbone Cancer Center Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05682443, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 22, 2026 · Synced Sep 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05682443 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →